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Trial record 82 of 160 for:    colon cancer AND Capecitabine AND Fluorouracil

A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.

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ClinicalTrials.gov Identifier: NCT01227707
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : August 15, 2014
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Radiation: Radiation therapy
Procedure: Mesorectal excision
Drug: 5-fluorouracil
Drug: leucovorin
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil
Hide Arm/Group Description Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Period Title: Overall Study
Started 43
Completed 19
Not Completed 24
Reason Not Completed
Adverse Event             10
Progression of disease             3
Withdrawal by Subject             1
Patient non-compliance             3
Medical decision             6
Death             1
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
Intent to treat (ITT) population: all participants who were included in the trial by signing the informed consent and were assigned to a study patient number.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
61.49  (10.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
18
  41.9%
Male
25
  58.1%
1.Primary Outcome
Title Percentage of Participants With Pathological Complete Response (pCR)
Hide Description pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.
Time Frame 6 to 8 weeks following completion of neoadjuvant treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants who underwent surgery and had pathological tumor stage data were included in the analysis.
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.00
(2.79 to 23.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bv+Capecitabine/Bv+Leucovorin+5-FU
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method one sample binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Hide Description The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed. The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated. The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI). Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline.
Time Frame Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: T0, N0 0
End of NAT: T0, N0 4.65
Baseline: T1, N0 0
End of NAT: T1, N0 4.65
Baseline: T1, NX 0
End of NAT: T1, NX 2.33
Baseline: T2, N0 0
End of NAT: T2, N0 18.60
Baseline: T2, N1 9.30
End of NAT: T2, N1 9.30
Baseline: T2, NX 0
End of NAT: T2, NX 6.98
Baseline: T3, N0 32.56
End of NAT: T3, N0 18.60
Baseline: T3, N1 46.51
End of NAT: T3, N1 9.30
Baseline: T3, N2 0
End of NAT: T3, N2 2.33
Baseline: T3, NX 2.33
End of NAT: T3, NX 6.98
Baseline: T4, N0 0
End of NAT: T4, N0 4.65
Baseline: T4, N1 2.33
End of NAT: T4, N1 0
Baseline: T4, N2 2.33
End of NAT: T4, N2 0
Baseline: T4, N3 2.33
End of NAT: T4, N3 0
Baseline: TX, N0 0
End of NAT: TX, N0 2.33
Baseline: TX, N2 2.33
End of NAT: TX, N2 0
Baseline: M0 97.67
End of NAT: M0 81.40
Baseline: M1 2.33
End of NAT: M1 2.33
Baseline: MX 0
End of NAT: MX 9.30
3.Secondary Outcome
Title Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
Hide Description [Not Specified]
Time Frame 6 to 8 weeks after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants who underwent surgery were included in the analysis. n (number) equals (=) number of participants assessed for the specified parameter (colostomy)
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
Anterior resection 70.0
Abdomen-peritoneal amputation (Miles) 22.5
Other 3.0
Colostomy, temporary (n=32) 47.50
Colostomy, definitive (n=32) 32.50
No colostomy 20.0
4.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment
Hide Description Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels.
Time Frame BL and within 6 weeks after the completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
CR of target lesion(s) 11.63
CR of non-target lesion(s) 18.60
5.Secondary Outcome
Title Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment
Hide Description Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels.
Time Frame BL and within 6 weeks after the completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
9.30
6.Secondary Outcome
Title Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment
Hide Description The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT.
Time Frame BL and within 6 weeks after the completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
4.65
7.Secondary Outcome
Title Percentage of Participants With Relapse During Follow-Up
Hide Description The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse.
Time Frame BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants who underwent radical surgery were included in the analysis
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: percentage of participants
No Relapse 84.21
1 Relapse 7.89
2 Relapses 7.89
8.Secondary Outcome
Title Disease-Free Survival (DFS) - Percentage of Participants With an Event
Hide Description DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause.
Time Frame BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
30.23
9.Secondary Outcome
Title DFS - Time to Event
Hide Description The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method.
Time Frame BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: months
27.43  (1.71)
10.Secondary Outcome
Title Overall Survival (OS) - Percentage of Participants With an Event
Hide Description OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive.
Time Frame BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
25.58
11.Secondary Outcome
Title OS - Time to Event
Hide Description OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method.
Time Frame BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: months
32.14  (1.46)
12.Secondary Outcome
Title Time to Disease Progression (TTP) - Percentage of Participants With an Event
Hide Description TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer.
Time Frame BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
27.91
13.Secondary Outcome
Title TTP - Time to Event
Hide Description TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method.
Time Frame BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: months
27.68  (1.72)
Time Frame Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
Adverse Event Reporting Description All enrolled participants who received at least 1 dose of study medication were included in the safety population.
 
Arm/Group Title Bv+Capecitabine/Bv+Leucovorin+5-FU
Hide Arm/Group Description Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
All-Cause Mortality
Bv+Capecitabine/Bv+Leucovorin+5-FU
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bv+Capecitabine/Bv+Leucovorin+5-FU
Affected / at Risk (%)
Total   8/42 (19.05%) 
Cardiac disorders   
Miocardic ischemia * 1  1/42 (2.38%) 
Cardiac ischemia * 1  1/42 (2.38%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/42 (2.38%) 
Bowel perforation * 1  1/42 (2.38%) 
Intestinal occlusion * 1  1/42 (2.38%) 
Injury, poisoning and procedural complications   
Anastomosis dehiscence * 1  1/42 (2.38%) 
Postoperative abscess * 1  1/42 (2.38%) 
Metabolism and nutrition disorders   
Ipokaliemia * 1  1/42 (2.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bv+Capecitabine/Bv+Leucovorin+5-FU
Affected / at Risk (%)
Total   39/42 (92.86%) 
Blood and lymphatic system disorders   
Anemia * 1  5/42 (11.90%) 
Leukopenia * 1  7/42 (16.67%) 
Neutropenia * 1  6/42 (14.29%) 
Thrombocytopenia * 1  1/42 (2.38%) 
Cardiac disorders   
Tachycardia * 1  1/42 (2.38%) 
Ear and labyrinth disorders   
Vertigo * 1  2/42 (4.76%) 
Eye disorders   
Conjunctivitis * 1  1/42 (2.38%) 
Gastrointestinal disorders   
Abdominal pain * 1  6/42 (14.29%) 
Constipation * 1  4/42 (9.52%) 
Diarrhea * 1  18/42 (42.86%) 
Hematochezia * 1  8/42 (19.05%) 
Nausea * 1  9/42 (21.43%) 
Proctalgia * 1  10/42 (23.81%) 
Proctitis * 1  5/42 (11.90%) 
Rectal hemorrhage * 1  3/42 (7.14%) 
Rectal tenesmus * 1  7/42 (16.67%) 
Anal fistula * 1  1/42 (2.38%) 
Anorectal discomfort * 1  2/42 (4.76%) 
Haemorrhoids * 1  1/42 (2.38%) 
Mucous stools * 1  2/42 (4.76%) 
Perianal erythema * 1  1/42 (2.38%) 
Stomatitis * 1  1/42 (2.38%) 
Vomiting * 1  1/42 (2.38%) 
General disorders   
Asthenia * 1  6/42 (14.29%) 
Fatigue * 1  4/42 (9.52%) 
Pyrexia * 1  3/42 (7.14%) 
Chest pain * 1  2/42 (4.76%) 
Mucosal inflammation * 1  2/42 (4.76%) 
Hepatobiliary disorders   
Hyperbilirubinaemia * 1  2/42 (4.76%) 
Hypertransaminasaemia * 1  1/42 (2.38%) 
Infections and infestations   
Cystitis * 1  4/42 (9.52%) 
Iatrogenic infection * 1  1/42 (2.38%) 
Influenza * 1  1/42 (2.38%) 
Oral herpes * 1  1/42 (2.38%) 
Injury, poisoning and procedural complications   
Gastrointestinal stoma complication * 1  1/42 (2.38%) 
Investigations   
Blood lactate dehydrogenase increased * 1  1/42 (2.38%) 
Transaminases abnormal * 1  1/42 (2.38%) 
Metabolism and nutrition disorders   
Hypokalaemia * 1  2/42 (4.76%) 
Hyperuricaemia * 1  1/42 (2.38%) 
Hypocalcaemia * 1  1/42 (2.38%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  2/42 (4.76%) 
Fistula * 1  1/42 (2.38%) 
Muscular weakness * 1  1/42 (2.38%) 
Musculoskeletal pain * 1  1/42 (2.38%) 
Pain in extremity * 1  1/42 (2.38%) 
Nervous system disorders   
Headache * 1  2/42 (4.76%) 
Neurotoxicity * 1  1/42 (2.38%) 
Paraesthesia * 1  2/42 (4.76%) 
Psychiatric disorders   
Anxiety * 1  1/42 (2.38%) 
Renal and urinary disorders   
Dysuria * 1  3/42 (7.14%) 
Haematuria * 1  1/42 (2.38%) 
Pollakiuria * 1  1/42 (2.38%) 
Proteinuria * 1  1/42 (2.38%) 
Strangury * 1  2/42 (4.76%) 
Reproductive system and breast disorders   
Prostatitis * 1  1/42 (2.38%) 
Vulvovaginal burning sensation * 1  1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  2/42 (4.76%) 
Hypoxia * 1  1/42 (2.38%) 
Oropharyngeal swelling * 1  1/42 (2.38%) 
Skin and subcutaneous tissue disorders   
Dermatitis * 1  1/42 (2.38%) 
Dermatitis exfoliative * 1  1/42 (2.38%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  1/42 (2.38%) 
Rash * 1  1/42 (2.38%) 
Vascular disorders   
Hypertension * 1  6/42 (14.29%) 
Arterial thrombosis * 1  1/42 (2.38%) 
Hypotension * 1  1/42 (2.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
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: NCT01227707     History of Changes
Other Study ID Numbers: ML18522
First Submitted: October 22, 2010
First Posted: October 25, 2010
Results First Submitted: May 28, 2014
Results First Posted: August 15, 2014
Last Update Posted: August 17, 2015