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Trial record 42 of 2066 for:    Pancreatic Cancer AND Digestive System Neoplasms

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.

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ClinicalTrials.gov Identifier: NCT00448136
Recruitment Status : Completed
First Posted : March 16, 2007
Results First Posted : January 22, 2015
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Interventions Drug: bevacizumab [Avastin]
Drug: 5 FU
Drug: Streptozotocin
Drug: Xeloda
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab + 5-fluorouracil (5-FU) + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 22; 5-FU 400 mg per square meter per day (mg/m^2/day) IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times. Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, orally (PO), twice daily (BID) on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Period Title: Overall Study
Started 34 49
Completed 30 41
Not Completed 4 8
Reason Not Completed
Death             3             8
Investigator's decision (progression)             1             0
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine Total
Hide Arm/Group Description Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times. Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times. Total of all reporting groups
Overall Number of Baseline Participants 34 49 83
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: all participants who received at least 1 dose of treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 49 participants 83 participants
55.93  (10.63) 61.64  (9.20) 59.29  (10.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 49 participants 83 participants
Female
12
  35.3%
23
  46.9%
35
  42.2%
Male
22
  64.7%
26
  53.1%
48
  57.8%
1.Primary Outcome
Title Progression-Free Survival (PFS) - Percentage of Participants With an Event
Hide Description PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 49
Measure Type: Number
Unit of Measure: percentage of participants
52.9 53.1
2.Primary Outcome
Title PFS - Time to Event
Hide Description PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 49
Median (95% Confidence Interval)
Unit of Measure: months
23.7 [1] 
(13.1 to NA)
23.4 [1] 
(13.2 to NA)
[1]
The upper limit for the median PFS was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
3.Primary Outcome
Title PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
Hide Description PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 49
Measure Type: Number
Unit of Measure: percentage of participants
12 months 76 65
24 months 50 48
4.Secondary Outcome
Title Percentage of Participants With a Response by Best Overall Response
Hide Description Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review. Complete response (CR): complete disappearance of all target lesions and non-target disease. All lesions, both target and non-target, must have decreased to normal (short axis, less than [<]10 millimeters [mm]). No new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD). PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data were missing from centralized review for 1 participant.
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PR (Investigator)
55.9
(39.2 to 72.6)
18.4
(7.5 to 29.2)
PR (Centralized review)
51.5
(34.5 to 68.6)
12.5
(3.1 to 21.9)
SD (Investigator)
44.1
(27.4 to 60.8)
69.4
(56.5 to 82.3)
SD (Centralized review)
48.5
(31.4 to 65.5)
81.3
(70.2 to 92.3)
PD (Investigator)
0
(0 to 0)
8.2
(0.5 to 15.8)
PD (Centralized review)
0
(0 to 0)
0
(0 to 0)
Not evaluable (Investigator)
0
(0 to 0)
4.1
(0.0 to 9.6)
Not evaluable (Centralized review)
0
(0 to 0)
6.3
(0.0 to 13.1)
5.Secondary Outcome
Title Duration of Overall Response (OR) - Percentage of Participants With an Event
Hide Description Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with a response of CR or PR were included in the analysis.
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 19 9
Measure Type: Number
Unit of Measure: percentage of participants
42.1 22.2
6.Secondary Outcome
Title Duration of OR - Time to Event
Hide Description Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median duration of OR was estimated using the Kaplan-Meier method.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with a response of CR or PR were included in the analysis.
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 19 9
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(11.2 to NA)
NA [2] 
(3.2 to NA)
[1]
Median duration and upper limit of the 95% confidence interval (CI) could not be calculated due to an insufficient number of events.
[2]
Median duration and upper limit of the 95% CI could not be calculated due to an insufficient number of events.
7.Secondary Outcome
Title Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months
Hide Description Duration of OR was determined only for those participants with an overall response of CR or PR and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 19 9
Measure Type: Number
Unit of Measure: percentage of participants
12 months 74 70
24 months 55 NA [1] 
[1]
Not evaluable as data from all participants were censored, or participants had experienced events of progression or death before the 24-month timepoint.
8.Secondary Outcome
Title Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event
Hide Description Determined only for those participants with overall disease control (CR, PR or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 43
Measure Type: Number
Unit of Measure: percentage of participants
52.9 46.5
9.Secondary Outcome
Title Duration of ODC - Time to Event
Hide Description Determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median time to event was estimated using the Kaplan-Meier method.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 43
Median (95% Confidence Interval)
Unit of Measure: months
22.3 [1] 
(11.9 to NA)
23.4 [1] 
(15.1 to NA)
[1]
The upper limit of the 95% CI was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
10.Secondary Outcome
Title Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months
Hide Description Duration of ODC was determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR, or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Time Frame Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 43
Measure Type: Number
Unit of Measure: percentage of participants
12 months 68 72
24 months 42 NA [1] 
[1]
Not evaluable as data from all participants were censored, or participants had experienced events of progression or death before the 24-month timepoint.
11.Secondary Outcome
Title Overall Survival (OS) - Percentage of Participants With an Event
Hide Description OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.
Time Frame Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 49
Measure Type: Number
Unit of Measure: percentage of participants
14.7 16.3
12.Secondary Outcome
Title OS - Time to Event
Hide Description OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit. Median OS was estimated using the Kaplan-Meier method.
Time Frame Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 49
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(27 to NA)
NA [2] 
(NA to NA)
[1]
The median (and upper 95% CI) OS was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
[2]
The median OS was not estimated because it was longer than the latest censoring time, and therefore was not achieved.
13.Secondary Outcome
Title OS - Percentage of Participants Surviving at 12 and 24 Months
Hide Description OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.
Time Frame Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 34 49
Measure Type: Number
Unit of Measure: percentage of participants
12 months 94 88
24 months 88 85
14.Secondary Outcome
Title Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Hide Description EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Time Frame Screening, every 3 months during treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. Number (n) equals (=) the number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 29 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=29,40) 65.23  (23.89) 65.42  (20.02)
3 months (n=20,32) 65.83  (19.48) 57.03  (22.41)
6 months (n=20,24) 60.00  (21.90) 66.32  (21.35)
12 months (n=13,14) 66.03  (17.83) 72.62  (19.46)
End of treatment (n=13,23) 64.74  (23.36) 57.97  (28.48)
15.Secondary Outcome
Title Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
Hide Description EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Changes from baseline were categorized as follows: Very much worsening (less than [<]-20); Moderate worsening (greater than or equal to [≥]-20 to <-10); Little worsening (≥-10 to <-5); No change (≥-5 to less than or equal to [≤]5); Little improvement (>5 to ≤10); Moderate improvement (>10 to ≤20); and Very much improved (>20).
Time Frame Screening, every 3 months during treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 20 29
Measure Type: Number
Unit of Measure: percentage of participants
3 months, Very much worsening (n=20,29) 10.0 17.2
3 months, Moderate worsening (n=20,29) 10.0 24.1
3 months, Little worsening (n=20,29) 10.0 17.2
3 months, No change (n=20,29) 40.0 24.1
3 months, Little improving (n=20,29) 5.0 3.4
3 months, Moderate Improving (n=20,29) 15.0 3.4
3 months, Very much improving (n=20,29) 10.0 10.3
6 months, Very much worsening (n=20,22) 15.0 22.7
6 months, Moderate worsening (n=20,22) 10.0 18.2
6 months, Little worsening (n=20,22) 5.0 0
6 months, No change (n=20,22) 35.0 31.8
6 months, Little improving (n=20,22) 10.0 13.6
6 months, Moderate Improving (n=20,22) 15.0 0
6 months, Very much improving (n=20,22) 10.0 13.6
12 months, Very much worsening (n=12,13) 8.3 0
12 months, Moderate worsening (n=12,13) 8.3 15.4
12 months - Little worsening (n=12,13) 33.3 15.4
12 months, No change (n=12,13) 25.0 38.5
12 months, Little improving (n=12,13) 8.3 7.7
12 months, Moderate Improving (n=12,13) 16.7 15.4
12 months, Very much improving (n=12,13) 0 7.7
End of treatment, Very much worsening (n=13,20) 15.4 15.0
End of treatment, Moderate worsening (n=13,20) 30.8 5.0
End of treatment, Little worsening (n=13,20) 0 10
End of treatment, No change (n=13,20) 15.4 45.0
End of treatment, Little improving (n=13,20) 15.4 10.0
End of treatment, Moderate Improving (n=13,20) 15.4 5.0
End of treatment, Very much improving (n=13,20) 7.7 10.0
16.Secondary Outcome
Title EORTC QLQ-C30 Functional and Symptom Scale Scores
Hide Description EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scale scores a higher level represents a more severe level of symptoms.
Time Frame Screening, every 3 months during treatment
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Hide Analysis Population Description
ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description:
Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
Overall Number of Participants Analyzed 30 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical functioning, Baseline (n=30,43) 90.44  (13.30) 87.71  (14.88)
Physical functioning, 3 months (n=22,33) 89.32  (12.77) 75.35  (24.07)
Physical functioning, 6 months (n=21,24) 81.98  (19.75) 82.50  (18.21)
Physical functioning, End of Treatment (n=13,24) 82.82  (20.21) 79.44  (19.85)
Role functioning, Baseline (n=30,43) 82.22  (27.31) 83.33  (25.46)
Role functioning, 3 months (n=22,33) 85.61  (21.39) 62.12  (33.66)
Role functioning, 6 months (n=21,24) 75.40  (29.16) 70.83  (28.34)
Role functioning, End of Treatment (n=13,24) 78.21  (32.90) 72.92  (29.00)
Emotional functioning, Baseline (n=30,42) 71.94  (28.32) 71.89  (20.50)
Emotional functioning, 3 months (n=21,33) 81.48  (20.53) 76.01  (24.27)
Emotional functioning, 6 months (n=21,24) 72.62  (28.28) 76.04  (26.27)
Emotional functioning, End of Treatment (n=13,24) 77.56  (23.17) 73.61  (24.04)
Cognitive functioning, Baseline (n=30,42) 86.67  (18.26) 87.30  (16.38)
Cognitive functioning, 3 months (n=22,33) 89.39  (15.04) 83.84  (21.03)
Cognitive functioning, 6 months (n=21,24) 83.33  (21.08) 82.64  (18.04)
Cognitive functioning, End of Treatment (n=13,24) 83.33  (22.57) 81.94  (25.97)
Social functioning, Baseline (n=30,41) 86.11  (21.48) 87.40  (20.34)
Social functioning, 3 months (n=22,33) 89.39  (17.48) 75.76  (27.35)
Social functioning, 6 months (n=21,24) 81.75  (26.30) 83.33  (21.42)
Social functioning, End of Treatment (n=13,24) 84.62  (24.96) 81.94  (21.93)
Fatigue, Baseline (n=30,42) 26.30  (23.61) 27.25  (21.70)
Fatigue, 3 months (n=21,33) 27.78  (23.70) 43.10  (31.76)
Fatigue, 6 months (n=20,24) 36.67  (29.09) 37.96  (23.61)
Fatigue, End of Treatment (n=13,24) 34.19  (28.85) 34.49  (32.93)
Nausea and vomiting, Baseline (n=30,42) 6.67  (14.91) 2.78  (7.29)
Nausea and vomiting, 3 months (n=22,33) 10.61  (14.13) 9.60  (16.15)
Nausea and vomiting, 6 months (n=21,24) 8.73  (17.97) 7.64  (12.98)
Nausea and vomiting, End of Treatment (n=13,24) 10.26  (19.88) 6.25  (14.59)
Pain, Baseline (n=30,43) 14.44  (19.44) 21.71  (27.83)
Pain, 3 months (n=22,33) 12.88  (18.50) 18.18  (25.47)
Pain, 6 months (n=21,24) 23.02  (31.83) 17.36  (19.95)
Pain, End of Treatment (n=13,24) 20.51  (28.18) 26.39  (32.94)
Dyspnea, Baseline (n=30,43) 16.67  (25.89) 16.28  (25.59)
Dyspnea, 3 months (n=21,33) 12.70  (19.65) 30.30  (32.66)
Dyspnea, 6 months (n=21,23) 19.05  (24.88) 23.19  (29.19)
Dyspnea, End of Treatment (n=13,24) 20.51  (28.99) 23.61  (30.26)
Insomnia, Baseline (n=30,43) 24.44  (27.59) 24.03  (24.48)
Insomnia, 3 months (n=21,33) 20.63  (22.30) 27.27  (30.57)
Insomnia, 6 months (n=21,24) 33.33  (34.96) 29.17  (30.00)
Insomnia, End of Treatment (n=13,24) 23.08  (25.04) 30.56  (33.93)
Appetite loss, Baseline (n=29,42) 12.64  (16.46) 8.73  (20.90)
Appetite loss, 3 months (n=22,33) 7.58  (14.30) 20.20  (24.92)
Appetite loss, 6 months (n=21,24) 15.87  (27.12) 25.00  (26.47)
Appetite loss, End of Treatment (n=13,24) 12.82  (28.99) 25.00  (32.97)
Constipation, Baseline (n=27,40) 4.94  (15.20) 10.00  (21.62)
Constipation, 3 months (n=21,33) 15.87  (27.12) 7.07  (18.18)
Constipation, 6 months (n=21,23) 17.46  (27.12) 11.59  (21.58)
Constipation, End of Treatment (n=13,24) 12.82  (21.68) 13.89  (25.85)
Diarrhea, Baseline (n=30,41) 13.33  (24.13) 37.40  (31.79)
Diarrhea, 3 months (n=22,32) 9.09  (21.04) 45.83  (34.65)
Diarrhea, 6 months (n=21,23) 6.35  (17.06) 43.48  (30.87)
Diarrhea, End of Treatment (n=12,22) 2.78  (9.62) 28.79  (31.36)
Financial difficulties, Baseline (n=30,413) 14.44  (25.80) 8.13  (17.92)
Financial difficulties, 3 months (n=22,33) 9.09  (15.19) 6.06  (15.49)
Financial difficulties, 6 months (n=21,23) 15.87  (24.99) 2.90  (9.60)
Financial difficulties, End of treatment (n=13,24) 17.95  (25.88) 4.17  (14.95)
Time Frame Adverse events (AEs) were collected from the date of first dose of study medication until 28 days after the last dose of study medication. Related serious AEs and AEs of special interest (AESIs) were recorded during follow-up.
Adverse Event Reporting Description All participants who received at least 1 dose of study treatment were included in the safety population. A separate analysis of nonserious AEs was not performed, therefore the AEs presented in the other nonserious AE table include all AEs reported during the study, not just nonserious events.
 
Arm/Group Title Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Hide Arm/Group Description Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times. Cycles 1-9 (21-Day cycle): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 2000 mg/m^2 tablets PO in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
All-Cause Mortality
Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   11/34 (32.35%)   13/49 (26.53%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  0/34 (0.00%)  1/49 (2.04%) 
Cardiac disorders     
Cardiac failure * 1  0/34 (0.00%)  1/49 (2.04%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/34 (0.00%)  2/49 (4.08%) 
Abdominal pain upper * 1  2/34 (5.88%)  0/49 (0.00%) 
Intestinal obstruction * 1  0/34 (0.00%)  2/49 (4.08%) 
Diarrhea * 1  0/34 (0.00%)  1/49 (2.04%) 
Gastrointestinal hemorrhage * 1  2/34 (5.88%)  0/49 (0.00%) 
Gastrointestinal perforation * 1  0/34 (0.00%)  1/49 (2.04%) 
General disorders     
Pyrexia * 1  3/34 (8.82%)  0/49 (0.00%) 
General physical health deterioration * 1  0/34 (0.00%)  2/49 (4.08%) 
Influenza like illness * 1  1/34 (2.94%)  0/49 (0.00%) 
Hemorrhage * 1  1/34 (2.94%)  1/49 (2.04%) 
Hepatobiliary disorders     
Jaundice * 1  1/34 (2.94%)  0/49 (0.00%) 
Immune system disorders     
Anaphylactic shock * 1  0/34 (0.00%)  1/49 (2.04%) 
Infections and infestations     
Post-procedural sepsis * 1  1/34 (2.94%)  0/49 (0.00%) 
Respiratory tract infection * 1  0/34 (0.00%)  1/49 (2.04%) 
Peritonitis * 1  0/34 (0.00%)  1/49 (2.04%) 
Injury, poisoning and procedural complications     
Chest injury * 1  0/34 (0.00%)  1/49 (2.04%) 
Wound * 1  0/34 (0.00%)  1/49 (2.04%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  2/34 (5.88%)  0/49 (0.00%) 
Decreased appetite * 1  0/34 (0.00%)  1/49 (2.04%) 
Nervous system disorders     
Cerebrovascular accident * 1  1/34 (2.94%)  0/49 (0.00%) 
Cerebral ischaemia * 1  0/34 (0.00%)  1/49 (2.04%) 
Cerebral infarction * 1  0/34 (0.00%)  1/49 (2.04%) 
Hemorrhagic stroke * 1  0/34 (0.00%)  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  1/34 (2.94%)  0/49 (0.00%) 
Pulmonary embolism * 1  1/34 (2.94%)  0/49 (0.00%) 
Vascular disorders     
Thrombotic microangiopathy * 1  1/34 (2.94%)  0/49 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab + 5-FU + Streptozocin Bevacizumab + Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   34/34 (100.00%)   49/49 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  4/34 (11.76%)  7/49 (14.29%) 
Neutropenia * 1  2/34 (5.88%)  8/49 (16.33%) 
Thrombocytopenia * 1  3/34 (8.82%)  6/49 (12.24%) 
Leukopenia * 1  1/34 (2.94%)  5/49 (10.20%) 
Lymphopenia * 1  2/34 (5.88%)  4/49 (8.16%) 
Febrile neutropenia * 1  0/34 (0.00%)  1/49 (2.04%) 
Cardiac disorders     
Tachycardia * 1  1/34 (2.94%)  1/49 (2.04%) 
Aortic valve incompetence * 1  0/34 (0.00%)  1/49 (2.04%) 
Cardiac disorder * 1  0/34 (0.00%)  1/49 (2.04%) 
Cardiac flutter * 1  0/34 (0.00%)  1/49 (2.04%) 
Cardiomyopathy * 1  0/34 (0.00%)  1/49 (2.04%) 
Non-obstructive cardiomyopathy * 1  0/34 (0.00%)  1/49 (2.04%) 
Palpitations * 1  0/34 (0.00%)  1/49 (2.04%) 
Sinus bradycardia * 1  0/34 (0.00%)  1/49 (2.04%) 
Ventricular extrasystoles * 1  0/34 (0.00%)  1/49 (2.04%) 
Ear and labyrinth disorders     
Hypoacusis * 1  1/34 (2.94%)  1/49 (2.04%) 
Tinnitus * 1  0/34 (0.00%)  2/49 (4.08%) 
Vertigo positional * 1  1/34 (2.94%)  0/49 (0.00%) 
Eye disorders     
Visual acuity reduced * 1  2/34 (5.88%)  0/49 (0.00%) 
Visual impairment * 1  1/34 (2.94%)  1/49 (2.04%) 
Conjunctivitis allergic * 1  1/34 (2.94%)  0/49 (0.00%) 
Dry eye * 1  0/34 (0.00%)  1/49 (2.04%) 
Eyelid oedema * 1  0/34 (0.00%)  1/49 (2.04%) 
Vision blurred * 1  0/34 (0.00%)  1/49 (2.04%) 
Gastrointestinal disorders     
Nausea * 1  24/34 (70.59%)  24/49 (48.98%) 
Diarrhoea * 1  12/34 (35.29%)  32/49 (65.31%) 
Constipation * 1  19/34 (55.88%)  9/49 (18.37%) 
Abdominal pain * 1  13/34 (38.24%)  12/49 (24.49%) 
Abdominal pain upper * 1  11/34 (32.35%)  11/49 (22.45%) 
Vomiting * 1  11/34 (32.35%)  7/49 (14.29%) 
Haemorrhoids * 1  4/34 (11.76%)  5/49 (10.20%) 
Dry mouth * 1  4/34 (11.76%)  4/49 (8.16%) 
Aphthous stomatitis * 1  3/34 (8.82%)  4/49 (8.16%) 
Gastrooesophageal reflux disease * 1  5/34 (14.71%)  2/49 (4.08%) 
Stomatitis * 1  3/34 (8.82%)  3/49 (6.12%) 
Dyspepsia * 1  2/34 (5.88%)  3/49 (6.12%) 
Flatulence * 1  2/34 (5.88%)  2/49 (4.08%) 
Anal fissure * 1  1/34 (2.94%)  2/49 (4.08%) 
Intestinal obstruction * 1  0/34 (0.00%)  3/49 (6.12%) 
Proctalgia * 1  0/34 (0.00%)  3/49 (6.12%) 
Toothache * 1  0/34 (0.00%)  3/49 (6.12%) 
Abdominal distension * 1  1/34 (2.94%)  1/49 (2.04%) 
Abdominal pain lower * 1  1/34 (2.94%)  1/49 (2.04%) 
Anorectal discomfort * 1  0/34 (0.00%)  2/49 (4.08%) 
Dysphagia * 1  0/34 (0.00%)  2/49 (4.08%) 
Gingival bleeding * 1  1/34 (2.94%)  1/49 (2.04%) 
Loose tooth * 1  1/34 (2.94%)  1/49 (2.04%) 
Abdominal discomfort * 1  0/34 (0.00%)  2/49 (4.08%) 
Abdominal rigidity * 1  0/34 (0.00%)  1/49 (2.04%) 
Faeces discoloured * 1  0/34 (0.00%)  1/49 (2.04%) 
Gastritis * 1  1/34 (2.94%)  0/49 (0.00%) 
Gastrointestinal motility disorder * 1  0/34 (0.00%)  1/49 (2.04%) 
Lip swelling * 1  0/34 (0.00%)  1/49 (2.04%) 
Proctitis * 1  0/34 (0.00%)  1/49 (2.04%) 
Salivary hypersecretion * 1  1/34 (2.94%)  0/49 (0.00%) 
Steatorrhoea * 1  1/34 (2.94%)  0/49 (0.00%) 
Tongue discolouration * 1  0/34 (0.00%)  1/49 (2.04%) 
Tongue haematoma * 1  1/34 (2.94%)  0/49 (0.00%) 
Varices oesophageal * 1  0/34 (0.00%)  1/49 (2.04%) 
General disorders     
Asthenia * 1  23/34 (67.65%)  28/49 (57.14%) 
Mucosal inflammation * 1  14/34 (41.18%)  17/49 (34.69%) 
Oedema peripheral * 1  4/34 (11.76%)  9/49 (18.37%) 
Pyrexia * 1  8/34 (23.53%)  4/49 (8.16%) 
Fatigue * 1  4/34 (11.76%)  5/49 (10.20%) 
Xerosis * 1  1/34 (2.94%)  3/49 (6.12%) 
Chest pain * 1  1/34 (2.94%)  2/49 (4.08%) 
Chills * 1  3/34 (8.82%)  0/49 (0.00%) 
General physical health deterioration * 1  0/34 (0.00%)  3/49 (6.12%) 
Influenza like illness * 1  3/34 (8.82%)  0/49 (0.00%) 
Malaise * 1  0/34 (0.00%)  2/49 (4.08%) 
Oedema * 1  2/34 (5.88%)  0/49 (0.00%) 
Catheter site haematoma * 1  1/34 (2.94%)  0/49 (0.00%) 
Catheter site pain * 1  1/34 (2.94%)  0/49 (0.00%) 
Drug intolerance * 1  0/34 (0.00%)  1/49 (2.04%) 
Face oedema * 1  0/34 (0.00%)  1/49 (2.04%) 
Implant site inflammation * 1  0/34 (0.00%)  1/49 (2.04%) 
Injection site pain * 1  0/34 (0.00%)  1/49 (2.04%) 
Mucosal dryness * 1  0/34 (0.00%)  1/49 (2.04%) 
Pain * 1  1/34 (2.94%)  0/49 (0.00%) 
Hepatobiliary disorders     
Portal hypertension * 1  2/34 (5.88%)  1/49 (2.04%) 
Cytolytic hepatitis * 1  2/34 (5.88%)  0/49 (0.00%) 
Biliary colic * 1  0/34 (0.00%)  1/49 (2.04%) 
Cholestasis * 1  0/34 (0.00%)  1/49 (2.04%) 
Hepatic pain * 1  0/34 (0.00%)  1/49 (2.04%) 
Jaundice * 1  1/34 (2.94%)  0/49 (0.00%) 
Immune system disorders     
Anaphylactic shock * 1  0/34 (0.00%)  1/49 (2.04%) 
Infections and infestations     
Nasopharyngitis * 1  4/34 (11.76%)  4/49 (8.16%) 
Bronchitis * 1  3/34 (8.82%)  3/49 (6.12%) 
Gastroenteritis * 1  2/34 (5.88%)  4/49 (8.16%) 
Pharyngitis * 1  2/34 (5.88%)  4/49 (8.16%) 
Urinary tract infection * 1  2/34 (5.88%)  4/49 (8.16%) 
Sinusitis * 1  2/34 (5.88%)  2/49 (4.08%) 
Tonsillitis * 1  3/34 (8.82%)  1/49 (2.04%) 
Cystitis * 1  1/34 (2.94%)  2/49 (4.08%) 
Herpes simplex * 1  1/34 (2.94%)  2/49 (4.08%) 
Infection * 1  1/34 (2.94%)  2/49 (4.08%) 
Oral herpes * 1  2/34 (5.88%)  1/49 (2.04%) 
Tooth abscess * 1  1/34 (2.94%)  2/49 (4.08%) 
Injection site infection * 1  1/34 (2.94%)  1/49 (2.04%) 
Rhinitis * 1  0/34 (0.00%)  2/49 (4.08%) 
Tooth infection * 1  0/34 (0.00%)  2/49 (4.08%) 
Candidiasis * 1  0/34 (0.00%)  1/49 (2.04%) 
Cholecystitis infective * 1  1/34 (2.94%)  0/49 (0.00%) 
Chronic sinusitis * 1  0/34 (0.00%)  1/49 (2.04%) 
Erysipelas * 1  0/34 (0.00%)  1/49 (2.04%) 
Folliculitis * 1  0/34 (0.00%)  1/49 (2.04%) 
Fungal infection * 1  0/34 (0.00%)  1/49 (2.04%) 
Gastroenteritis escherichia coli * 1  0/34 (0.00%)  1/49 (2.04%) 
Gastroenteritis viral * 1  0/34 (0.00%)  1/49 (2.04%) 
Herpes zoster ophthalmic * 1  0/34 (0.00%)  1/49 (2.04%) 
Hordeolum * 1  1/34 (2.94%)  0/49 (0.00%) 
Infected cyst * 1  1/34 (2.94%)  0/49 (0.00%) 
Laryngitis * 1  0/34 (0.00%)  1/49 (2.04%) 
Oral candidiasis * 1  0/34 (0.00%)  1/49 (2.04%) 
Post procedural sepsis * 1  1/34 (2.94%)  0/49 (0.00%) 
Respiratory tract infection * 1  0/34 (0.00%)  1/49 (2.04%) 
Staphylococcal infection * 1  0/34 (0.00%)  1/49 (2.04%) 
Tracheobronchitis * 1  1/34 (2.94%)  0/49 (0.00%) 
Injury, poisoning and procedural complications     
Wound * 1  0/34 (0.00%)  2/49 (4.08%) 
Ankle fracture * 1  1/34 (2.94%)  0/49 (0.00%) 
Bite * 1  0/34 (0.00%)  1/49 (2.04%) 
Burn of internal organs * 1  0/34 (0.00%)  1/49 (2.04%) 
Chest injury * 1  0/34 (0.00%)  1/49 (2.04%) 
Contusion * 1  1/34 (2.94%)  0/49 (0.00%) 
Fall * 1  0/34 (0.00%)  1/49 (2.04%) 
Fibula fracture * 1  0/34 (0.00%)  1/49 (2.04%) 
Frostbite * 1  1/34 (2.94%)  0/49 (0.00%) 
Iatrogenic injury * 1  0/34 (0.00%)  1/49 (2.04%) 
Limb injury * 1  1/34 (2.94%)  0/49 (0.00%) 
Multiple fractures * 1  0/34 (0.00%)  1/49 (2.04%) 
Muscle strain * 1  0/34 (0.00%)  1/49 (2.04%) 
Radiation mucositis * 1  1/34 (2.94%)  0/49 (0.00%) 
Rib fracture * 1  1/34 (2.94%)  1/49 (2.04%) 
Investigations     
Weight decreased * 1  4/34 (11.76%)  5/49 (10.20%) 
Blood bilirubin abnormal * 1  0/34 (0.00%)  2/49 (4.08%) 
Activated partial thromboplastin time prolonged * 1  1/34 (2.94%)  0/49 (0.00%) 
Alanine aminotransferase abnormal * 1  1/34 (2.94%)  0/49 (0.00%) 
Alanine aminotransferase increased * 1  1/34 (2.94%)  0/49 (0.00%) 
Aspartate aminotransferase increased * 1  1/34 (2.94%)  0/49 (0.00%) 
Blood creatinine decreased * 1  1/34 (2.94%)  0/49 (0.00%) 
Blood creatinine increased * 1  1/34 (2.94%)  0/49 (0.00%) 
Cardiac murmur * 1  0/34 (0.00%)  1/49 (2.04%) 
Creatinine renal clearance decreased * 1  1/34 (2.94%)  0/49 (0.00%) 
Gamma-glutamyltransferase abnormal * 1  1/34 (2.94%)  0/49 (0.00%) 
Gamma-glutamyltransferase increased * 1  1/34 (2.94%)  0/49 (0.00%) 
Haemoglobin * 1  0/34 (0.00%)  1/49 (2.04%) 
Lipase increased * 1  1/34 (2.94%)  0/49 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  5/34 (14.71%)  6/49 (12.24%) 
Hyperglycaemia * 1  3/34 (8.82%)  4/49 (8.16%) 
Anorexia * 1  2/34 (5.88%)  2/49 (4.08%) 
Hypokalaemia * 1  0/34 (0.00%)  4/49 (8.16%) 
Gout * 1  1/34 (2.94%)  2/49 (4.08%) 
Hypocalcaemia * 1  0/34 (0.00%)  3/49 (6.12%) 
Hypoglycaemia * 1  3/34 (8.82%)  0/49 (0.00%) 
Vitamin D deficiency * 1  2/34 (5.88%)  0/49 (0.00%) 
Dehydration * 1  0/34 (0.00%)  1/49 (2.04%) 
Diabetes mellitus inadequate control * 1  1/34 (2.94%)  0/49 (0.00%) 
Food intolerance * 1  0/34 (0.00%)  1/49 (2.04%) 
Hyperkalaemia * 1  0/34 (0.00%)  1/49 (2.04%) 
Hypertriglyceridaemia * 1  0/34 (0.00%)  1/49 (2.04%) 
Hypoglycaemic unconsciousness * 1  1/34 (2.94%)  0/49 (0.00%) 
Hyposideraemia * 1  1/34 (2.94%)  0/49 (0.00%) 
Iron deficiency * 1  0/34 (0.00%)  1/49 (2.04%) 
Malnutrition * 1  1/34 (2.94%)  0/49 (0.00%) 
Vitamin K deficiency * 1  0/34 (0.00%)  1/49 (2.04%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  8/34 (23.53%)  6/49 (12.24%) 
Back pain * 1  6/34 (17.65%)  4/49 (8.16%) 
Musculoskeletal pain * 1  3/34 (8.82%)  3/49 (6.12%) 
Neck pain * 1  2/34 (5.88%)  4/49 (8.16%) 
Myalgia * 1  4/34 (11.76%)  0/49 (0.00%) 
Pain in extremity * 1  2/34 (5.88%)  2/49 (4.08%) 
Flank pain * 1  1/34 (2.94%)  2/49 (4.08%) 
Bone pain * 1  0/34 (0.00%)  2/49 (4.08%) 
Tendon disorder * 1  1/34 (2.94%)  1/49 (2.04%) 
Haemarthrosis * 1  1/34 (2.94%)  0/49 (0.00%) 
Muscle fatigue * 1  0/34 (0.00%)  1/49 (2.04%) 
Muscle spasms * 1  0/34 (0.00%)  1/49 (2.04%) 
Musculoskeletal chest pain * 1  0/34 (0.00%)  1/49 (2.04%) 
Osteoarthritis * 1  1/34 (2.94%)  0/49 (0.00%) 
Pain in jaw * 1  1/34 (2.94%)  0/49 (0.00%) 
Rheumatoid arthritis * 1  0/34 (0.00%)  1/49 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm progression * 1  1/34 (2.94%)  0/49 (0.00%) 
Pyogenic granuloma * 1  0/34 (0.00%)  1/49 (2.04%) 
Skin papilloma * 1  1/34 (2.94%)  0/49 (0.00%) 
Nervous system disorders     
Headache * 1  13/34 (38.24%)  14/49 (28.57%) 
Paraesthesia * 1  4/34 (11.76%)  4/49 (8.16%) 
Dizziness * 1  3/34 (8.82%)  4/49 (8.16%) 
Dysgeusia * 1  0/34 (0.00%)  4/49 (8.16%) 
Dysaesthesia * 1  1/34 (2.94%)  1/49 (2.04%) 
Migraine * 1  0/34 (0.00%)  2/49 (4.08%) 
Neuropathy peripheral * 1  1/34 (2.94%)  1/49 (2.04%) 
Sciatica * 1  1/34 (2.94%)  1/49 (2.04%) 
Ageusia * 1  0/34 (0.00%)  1/49 (2.04%) 
Amnesia * 1  1/34 (2.94%)  0/49 (0.00%) 
Balance disorder * 1  0/34 (0.00%)  1/49 (2.04%) 
Burning sensation * 1  1/34 (2.94%)  0/49 (0.00%) 
Epilepsy * 1  1/34 (2.94%)  0/49 (0.00%) 
Hypokinesia * 1  1/34 (2.94%)  0/49 (0.00%) 
Loss of consciousness * 1  1/34 (2.94%)  0/49 (0.00%) 
Parkinson's disease * 1  0/34 (0.00%)  1/49 (2.04%) 
Presyncope * 1  0/34 (0.00%)  1/49 (2.04%) 
Sensory disturbance * 1  1/34 (2.94%)  0/49 (0.00%) 
Transient ischaemic attack * 1  1/34 (2.94%)  0/49 (0.00%) 
Tremor * 1  0/34 (0.00%)  1/49 (2.04%) 
Psychiatric disorders     
Anxiety * 1  6/34 (17.65%)  6/49 (12.24%) 
Insomnia * 1  4/34 (11.76%)  5/49 (10.20%) 
Depression * 1  1/34 (2.94%)  3/49 (6.12%) 
Confusional state * 1  0/34 (0.00%)  3/49 (6.12%) 
Sleep disorder * 1  0/34 (0.00%)  2/49 (4.08%) 
Stress * 1  0/34 (0.00%)  1/49 (2.04%) 
Renal and urinary disorders     
Glycosuria * 1  0/34 (0.00%)  3/49 (6.12%) 
Dysuria * 1  1/34 (2.94%)  1/49 (2.04%) 
Renal failure * 1  2/34 (5.88%)  0/49 (0.00%) 
Albuminuria * 1  0/34 (0.00%)  1/49 (2.04%) 
Leukocyturia * 1  0/34 (0.00%)  1/49 (2.04%) 
Polyuria * 1  0/34 (0.00%)  1/49 (2.04%) 
Urinary incontinence * 1  0/34 (0.00%)  1/49 (2.04%) 
Reproductive system and breast disorders     
Epididymitis * 1  0/34 (0.00%)  1/49 (2.04%) 
Erosive balanitis * 1  0/34 (0.00%)  1/49 (2.04%) 
Metrorrhagia * 1  0/34 (0.00%)  1/49 (2.04%) 
Testicular pain * 1  0/34 (0.00%)  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/34 (8.82%)  5/49 (10.20%) 
Dyspnoea * 1  2/34 (5.88%)  2/49 (4.08%) 
Rhinorrhoea * 1  2/34 (5.88%)  2/49 (4.08%) 
Dysphonia * 1  1/34 (2.94%)  2/49 (4.08%) 
Dyspnoea extertional * 1  1/34 (2.94%)  2/49 (4.08%) 
Pleural effusion * 1  1/34 (2.94%)  1/49 (2.04%) 
Nasal dryness * 1  1/34 (2.94%)  0/49 (0.00%) 
Pneumonia aspiration * 1  0/34 (0.00%)  1/49 (2.04%) 
Sleep apnoea syndrome * 1  0/34 (0.00%)  1/49 (2.04%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome * 1  6/34 (17.65%)  31/49 (63.27%) 
Pruritus * 1  5/34 (14.71%)  7/49 (14.29%) 
Dry skin * 1  3/34 (8.82%)  8/49 (16.33%) 
Erythema * 1  3/34 (8.82%)  4/49 (8.16%) 
Rash * 1  3/34 (8.82%)  1/49 (2.04%) 
Alopecia * 1  2/34 (5.88%)  1/49 (2.04%) 
Acne * 1  1/34 (2.94%)  1/49 (2.04%) 
Angioedema * 1  1/34 (2.94%)  1/49 (2.04%) 
Hyperkeratosis palmaris and plantaris * 1  1/34 (2.94%)  1/49 (2.04%) 
Petechiae * 1  0/34 (0.00%)  2/49 (4.08%) 
Pigmentation disorder * 1  0/34 (0.00%)  2/49 (4.08%) 
Skin hyperpigmentation * 1  0/34 (0.00%)  2/49 (4.08%) 
Skin lesion * 1  1/34 (2.94%)  1/49 (2.04%) 
Urticaria * 1  1/34 (2.94%)  1/49 (2.04%) 
Dermatitis * 1  0/34 (0.00%)  1/49 (2.04%) 
Dyshidrosis * 1  0/34 (0.00%)  1/49 (2.04%) 
Nail discomfort * 1  0/34 (0.00%)  1/49 (2.04%) 
Nail disorder * 1  0/34 (0.00%)  1/49 (2.04%) 
Nail toxicity * 1  0/34 (0.00%)  1/49 (2.04%) 
Night sweats * 1  0/34 (0.00%)  1/49 (2.04%) 
Onychoclasis * 1  0/34 (0.00%)  1/49 (2.04%) 
Photosensitivity reaction * 1  0/34 (0.00%)  1/49 (2.04%) 
Purpura * 1  0/34 (0.00%)  1/49 (2.04%) 
Skin chapped * 1  0/34 (0.00%)  1/49 (2.04%) 
Skin discolouration * 1  1/34 (2.94%)  0/49 (0.00%) 
Skin fissures * 1  0/34 (0.00%)  1/49 (2.04%) 
Skin reaction * 1  1/34 (2.94%)  0/49 (0.00%) 
Skin toxicity * 1  0/34 (0.00%)  1/49 (2.04%) 
Spider naevus * 1  0/34 (0.00%)  1/49 (2.04%) 
Vascular disorders     
Flushing * 1  2/34 (5.88%)  9/49 (18.37%) 
Hot flush * 1  3/34 (8.82%)  1/49 (2.04%) 
Hypotension * 1  0/34 (0.00%)  2/49 (4.08%) 
Haematoma * 1  0/34 (0.00%)  1/49 (2.04%) 
Varicose vein * 1  1/34 (2.94%)  0/49 (0.00%) 
Vein discolouration * 1  0/34 (0.00%)  1/49 (2.04%) 
Venous insufficiency * 1  0/34 (0.00%)  1/49 (2.04%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00448136     History of Changes
Other Study ID Numbers: ML20383
First Submitted: March 15, 2007
First Posted: March 16, 2007
Results First Submitted: October 31, 2014
Results First Posted: January 22, 2015
Last Update Posted: January 22, 2015