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Trial record 34 of 435 for:    colon cancer AND Capecitabine

Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00022698
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 15, 2016
Last Update Posted : April 15, 2016
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: Capecitabine
Drug: Irinotecan
Enrollment 67
Recruitment Details A total of 67 participants were enrolled in the study, which was conducted from 18 May 2001 to 9 December 2004 at 18 study centers in the United States.
Pre-assignment Details Data for participants who completed 12 cycles of the study treatment is presented.
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description Participants received capecitabine (Xeloda) 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first). Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Period Title: Overall Study
Started 15 52
Completed 7 17
Not Completed 8 35
Reason Not Completed
Adverse Event             5             9
Death             0             2
Failure to return             0             1
Refused treatment             0             2
Insufficient therapeutic response             2             14
Administrative /other             1             7
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) Total
Hide Arm/Group Description Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first). Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first). Total of all reporting groups
Overall Number of Baseline Participants 15 52 67
Hide Baseline Analysis Population Description
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 52 participants 67 participants
63.1  (8.3) 61.4  (11.1) 61.8  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 52 participants 67 participants
Female
9
  60.0%
21
  40.4%
30
  44.8%
Male
6
  40.0%
31
  59.6%
37
  55.2%
1.Primary Outcome
Title Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)
Hide Description Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR.
Time Frame Approximately 43 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.
Arm/Group Title Cohort 1, Initial Regimen:(Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description:
Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Overall Number of Participants Analyzed 15 52
Measure Type: Number
Unit of Measure: percentage of participants
CR 7 2
PR 40 42
2.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to disease progression was assessed as the time from start of treatment to the time the participant was first recorded as having disease progression or died due to causes other than disease progression. If a participant never progressed while being followed, he/she was censored at the date of the last tumor assessment or the date of the last dose if no post-baseline tumor measurement was available.
Time Frame Approximately 43 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description:
Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Overall Number of Participants Analyzed 15 52
Median (95% Confidence Interval)
Unit of Measure: months
6.1
(3.4 to 9.0)
7.6
(5.8 to 8.7)
3.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure was assessed as the time from start of treatment to the time the participant was withdrawn due to any of the reasons such as adverse events, progressive disease, insufficient therapeutic response, death, failure to return, or refused treatment, did not cooperate or withdrew consent.
Time Frame Approximately 43 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description:
Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Overall Number of Participants Analyzed 15 52
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(2.4 to 9.2)
7.3
(4.6 to 9.5)
4.Secondary Outcome
Title Percentage of Participants With One-year Survival
Hide Description Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first.
Time Frame Up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description:
Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Overall Number of Participants Analyzed 15 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67
(43 to 91)
71
(58 to 83)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival is defined as the time from start of treatment to the date of death. Participants who did not die were censored at the last date the participant was known to be alive.
Time Frame Approximately 43 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description:
Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Overall Number of Participants Analyzed 15 52
Median (95% Confidence Interval)
Unit of Measure: months
22.9
(10.1 to 28.2)
20.5
(14.9 to 30.0)
6.Secondary Outcome
Title Time To Objective Response
Hide Description The time to objective response is defined as the time from start of treatment to the date of first objective response. Participants who never responded during study were censored at the last tumor assessment or the date of last dose, whichever was later, or at the date of death if occurring prior to response.
Time Frame Approximately 43 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description:
Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Overall Number of Participants Analyzed 15 52
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(2.7 to 8.6)
4.3
(2.6 to 9.6)
7.Secondary Outcome
Title Duration of Overall Response
Hide Description Duration of overall response was assessed from the time that measurement criteria were first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease was documented. It was analyzed for responders only. Participants without observed progressive disease after an objective response were censored at the date of the last tumor assessment.
Time Frame Approximately 43 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description:
Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Overall Number of Participants Analyzed 7 23
Median (95% Confidence Interval)
Unit of Measure: months
7.0
(2.6 to 9.2)
7.7
(5.8 to 11.5)
8.Secondary Outcome
Title Duration of Overall Complete Response
Hide Description The duration of overall complete response was assessed from the time that measurement criteria were met for complete response until the first date that recurrent or progressive disease was objectively documented. Participants without observed progressive disease after an objective complete response were censored at the date of the last tumor assessment.
Time Frame Approximately 43 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description:
Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: months
12.45 12.68
9.Secondary Outcome
Title Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths
Hide Description An adverse event (AEs) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), life-threatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.
Time Frame Approximately 43 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all participants who received at least 1 dose of any study drug and had at least one post-baseline safety assessment. This included participants in Cohort 1 and Cohort 2.
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) Total Participants (Cohort 1 + Cohort 2)
Hide Arm/Group Description:
Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Total of all reporting groups.
Overall Number of Participants Analyzed 15 52 67
Measure Type: Number
Unit of Measure: Number of participants
Any AEs 15 52 67
SAEs 10 25 35
Deaths During Study 0 3 3
Deaths During Follow-up 13 23 36
Time Frame Approximately 43 Months
Adverse Event Reporting Description Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
 
Arm/Group Title Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Hide Arm/Group Description Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first). Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
All-Cause Mortality
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/15 (66.67%)   25/52 (48.08%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/15 (6.67%)  1/52 (1.92%) 
Cardiac disorders     
Atrial fibrillation  1  0/15 (0.00%)  1/52 (1.92%) 
Gastrointestinal disorders     
Diarrhoea  1  2/15 (13.33%)  5/52 (9.62%) 
Small intestinal obstruction  1  0/15 (0.00%)  6/52 (11.54%) 
Constipation  1  0/15 (0.00%)  1/52 (1.92%) 
Enterocolitis  1  0/15 (0.00%)  1/52 (1.92%) 
Ileitis  1  0/15 (0.00%)  1/52 (1.92%) 
Ileus  1  0/15 (0.00%)  1/52 (1.92%) 
Colitis  1  1/15 (6.67%)  0/52 (0.00%) 
General disorders     
Pyrexia  1  0/15 (0.00%)  1/52 (1.92%) 
Hepatobiliary disorders     
Bile duct obstruction  1  0/15 (0.00%)  1/52 (1.92%) 
Infections and infestations     
Cellulitis  1  0/15 (0.00%)  1/52 (1.92%) 
Localised infection  1  0/15 (0.00%)  1/52 (1.92%) 
Pneumonia staphylococcal  1  0/15 (0.00%)  1/52 (1.92%) 
Pneumonia  1  1/15 (6.67%)  0/52 (0.00%) 
Sepsis  1  1/15 (6.67%)  0/52 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  3/15 (20.00%)  4/52 (7.69%) 
Hyperglycaemia  1  1/15 (6.67%)  0/52 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to central nervous system  1  1/15 (6.67%)  0/52 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  1/15 (6.67%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  2/15 (13.33%)  2/52 (3.85%) 
Vascular disorders     
Deep vein thrombosis  1  2/15 (13.33%)  3/52 (5.77%) 
Aortic thrombosis  1  0/15 (0.00%)  1/52 (1.92%) 
Haemorrhage  1  0/15 (0.00%)  1/52 (1.92%) 
Vasoconstriction  1  0/15 (0.00%)  1/52 (1.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 1.5
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)
Affected / at Risk (%) Affected / at Risk (%)
Total   15/15 (100.00%)   52/52 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  6/15 (40.00%)  18/52 (34.62%) 
Neutropenia  1  5/15 (33.33%)  16/52 (30.77%) 
Thrombocytopenia  1  0/15 (0.00%)  4/52 (7.69%) 
Leukopenia  1  0/15 (0.00%)  3/52 (5.77%) 
Coagulopathy  1  1/15 (6.67%)  0/52 (0.00%) 
Cardiac disorders     
Tachycardia  1  1/15 (6.67%)  2/52 (3.85%) 
Bradycardia  1  1/15 (6.67%)  0/52 (0.00%) 
Ear and labyrinth disorders     
Ear disorder  1  1/15 (6.67%)  0/52 (0.00%) 
Vertigo  1  1/15 (6.67%)  0/52 (0.00%) 
Eye disorders     
Dry eye  1  1/15 (6.67%)  2/52 (3.85%) 
Conjunctivitis  1  1/15 (6.67%)  1/52 (1.92%) 
Vision blurred  1  1/15 (6.67%)  1/52 (1.92%) 
Gastrointestinal disorders     
Diarrhoea  1  13/15 (86.67%)  45/52 (86.54%) 
Nausea  1  13/15 (86.67%)  34/52 (65.38%) 
Vomiting  1  7/15 (46.67%)  26/52 (50.00%) 
Abdominal pain  1  6/15 (40.00%)  24/52 (46.15%) 
Constipation  1  5/15 (33.33%)  17/52 (32.69%) 
Flatulence  1  0/15 (0.00%)  9/52 (17.31%) 
Dyspepsia  1  1/15 (6.67%)  7/52 (13.46%) 
Abdominal pain upper  1  0/15 (0.00%)  6/52 (11.54%) 
Stomatitis  1  1/15 (6.67%)  5/52 (9.62%) 
Dry mouth  1  1/15 (6.67%)  3/52 (5.77%) 
Abdominal distension  1  0/15 (0.00%)  3/52 (5.77%) 
Ascites  1  0/15 (0.00%)  3/52 (5.77%) 
Gastrooesophageal reflux disease  1  0/15 (0.00%)  3/52 (5.77%) 
Haemorrhoids  1  0/15 (0.00%)  3/52 (5.77%) 
Rectal haemorrhage  1  0/15 (0.00%)  3/52 (5.77%) 
Toothache  1  1/15 (6.67%)  2/52 (3.85%) 
Abdominal hernia  1  1/15 (6.67%)  1/52 (1.92%) 
Gastritis  1  1/15 (6.67%)  1/52 (1.92%) 
Mouth ulceration  1  1/15 (6.67%)  1/52 (1.92%) 
Colonic obstruction  1  1/15 (6.67%)  0/52 (0.00%) 
Frequent bowel movements  1  1/15 (6.67%)  0/52 (0.00%) 
Loose stools  1  1/15 (6.67%)  0/52 (0.00%) 
Melaena  1  1/15 (6.67%)  0/52 (0.00%) 
General disorders     
Fatigue  1  8/15 (53.33%)  32/52 (61.54%) 
Oedema peripheral  1  1/15 (6.67%)  14/52 (26.92%) 
Pyrexia  1  1/15 (6.67%)  9/52 (17.31%) 
Asthenia  1  3/15 (20.00%)  7/52 (13.46%) 
Mucosal inflammation  1  2/15 (13.33%)  5/52 (9.62%) 
Chest pain  1  0/15 (0.00%)  3/52 (5.77%) 
Gait disturbance  1  1/15 (6.67%)  1/52 (1.92%) 
Discomfort  1  1/15 (6.67%)  0/52 (0.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  1/15 (6.67%)  2/52 (3.85%) 
Infections and infestations     
Upper respiratory tract infection  1  0/15 (0.00%)  6/52 (11.54%) 
Candidiasis  1  0/15 (0.00%)  3/52 (5.77%) 
Nasopharyngitis  1  0/15 (0.00%)  3/52 (5.77%) 
Sinusitis  1  0/15 (0.00%)  3/52 (5.77%) 
Gastroenteritis viral  1  1/15 (6.67%)  1/52 (1.92%) 
Herpes simplex  1  1/15 (6.67%)  1/52 (1.92%) 
Bacteraemia  1  1/15 (6.67%)  0/52 (0.00%) 
Enterocolitis infectious  1  1/15 (6.67%)  0/52 (0.00%) 
Herpes virus infection  1  1/15 (6.67%)  0/52 (0.00%) 
Nail bed infection  1  1/15 (6.67%)  0/52 (0.00%) 
Rhinitis  1  1/15 (6.67%)  0/52 (0.00%) 
Injury, poisoning and procedural complications     
Excoriation  1  1/15 (6.67%)  0/52 (0.00%) 
Meniscus lesion  1  1/15 (6.67%)  0/52 (0.00%) 
Investigations     
Weight decreased  1  3/15 (20.00%)  4/52 (7.69%) 
Blood bilirubin increased  1  0/15 (0.00%)  4/52 (7.69%) 
Weight increased  1  1/15 (6.67%)  2/52 (3.85%) 
Faecal occult blood positive  1  1/15 (6.67%)  0/52 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  3/15 (20.00%)  13/52 (25.00%) 
Anorexia  1  2/15 (13.33%)  13/52 (25.00%) 
Dehydration  1  2/15 (13.33%)  11/52 (21.15%) 
Hyponatraemia  1  1/15 (6.67%)  3/52 (5.77%) 
Decreased appetite  1  1/15 (6.67%)  2/52 (3.85%) 
Electrolyte imbalance  1  2/15 (13.33%)  1/52 (1.92%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  0/15 (0.00%)  8/52 (15.38%) 
Back pain  1  2/15 (13.33%)  5/52 (9.62%) 
Arthralgia  1  0/15 (0.00%)  6/52 (11.54%) 
Myalgia  1  0/15 (0.00%)  4/52 (7.69%) 
Muscle cramp  1  1/15 (6.67%)  1/52 (1.92%) 
Groin pain  1  1/15 (6.67%)  0/52 (0.00%) 
Muscle twitching  1  1/15 (6.67%)  0/52 (0.00%) 
Nervous system disorders     
Headache  1  3/15 (20.00%)  3/52 (5.77%) 
Paraesthesia  1  0/15 (0.00%)  4/52 (7.69%) 
Dysgeusia  1  1/15 (6.67%)  3/52 (5.77%) 
Dizziness  1  3/15 (20.00%)  1/52 (1.92%) 
Neuropathy peripheral  1  1/15 (6.67%)  0/52 (0.00%) 
Sciatica  1  1/15 (6.67%)  0/52 (0.00%) 
Syncope  1  1/15 (6.67%)  0/52 (0.00%) 
Psychiatric disorders     
Depression  1  1/15 (6.67%)  10/52 (19.23%) 
Insomnia  1  2/15 (13.33%)  6/52 (11.54%) 
Anxiety  1  1/15 (6.67%)  3/52 (5.77%) 
Renal and urinary disorders     
Dysuria  1  1/15 (6.67%)  3/52 (5.77%) 
Haematuria  1  1/15 (6.67%)  2/52 (3.85%) 
Renal failure acute  1  1/15 (6.67%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/15 (13.33%)  5/52 (9.62%) 
Cough  1  1/15 (6.67%)  4/52 (7.69%) 
Epistaxis  1  0/15 (0.00%)  4/52 (7.69%) 
Pharyngolaryngeal pain  1  0/15 (0.00%)  4/52 (7.69%) 
Pleural effusion  1  1/15 (6.67%)  3/52 (5.77%) 
Hiccups  1  1/15 (6.67%)  1/52 (1.92%) 
Pharyngeal ulceration  1  1/15 (6.67%)  0/52 (0.00%) 
Pleuritic pain  1  1/15 (6.67%)  0/52 (0.00%) 
Respiratory tract congestion  1  1/15 (6.67%)  0/52 (0.00%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome  1  7/15 (46.67%)  24/52 (46.15%) 
Alopecia  1  3/15 (20.00%)  18/52 (34.62%) 
Rash  1  2/15 (13.33%)  12/52 (23.08%) 
Dry skin  1  1/15 (6.67%)  4/52 (7.69%) 
Erythema  1  0/15 (0.00%)  3/52 (5.77%) 
Pruritus  1  1/15 (6.67%)  2/52 (3.85%) 
Seborrhoeic dermatitis  1  1/15 (6.67%)  0/52 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/15 (6.67%)  3/52 (5.77%) 
Hypotension  1  1/15 (6.67%)  1/52 (1.92%) 
Hot flush  1  1/15 (6.67%)  1/52 (1.92%) 
Poor venous access  1  1/15 (6.67%)  1/52 (1.92%) 
Hypertension  1  1/15 (6.67%)  0/52 (0.00%) 
Phlebothrombosis  1  1/15 (6.67%)  0/52 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 1.5
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 that 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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 61 6878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00022698     History of Changes
Other Study ID Numbers: ML16323
First Submitted: August 10, 2001
First Posted: January 27, 2003
Results First Submitted: March 16, 2016
Results First Posted: April 15, 2016
Last Update Posted: April 15, 2016