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PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.
OBJECTIVES:
Primary:
Secondary:
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1,Initial Regimen:(Capecitabine + Irinotecan ) | Experimental | Participants will receive 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 will be administered. At the discretion of the investigator, participants who are responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first). |
|
| Cohort 2,Amended Regimen:(Capecitabine + Irinotecan) | Experimental | Participants will receive 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 intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who will be responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0) | 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. | Approximately 43 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression | 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. |
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DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma
At least 1 measurable lesion
No evidence of CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16943524 | Result | Meropol NJ, Gold PJ, Diasio RB, Andria M, Dhami M, Godfrey T, Kovatich AJ, Lund KA, Mitchell E, Schwarting R. Thymidine phosphorylase expression is associated with response to capecitabine plus irinotecan in patients with metastatic colorectal cancer. J Clin Oncol. 2006 Sep 1;24(25):4069-77. doi: 10.1200/JCO.2005.05.2084. | |
| 15709193 |
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Data for participants who completed 12 cycles of the study treatment is presented.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Irinotecan |
| Drug |
|
| Approximately 43 Months |
| Time to Treatment Failure | 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. | Approximately 43 Months |
| Percentage of Participants With One-year Survival | Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first. | Up to Month 12 |
| Overall Survival | 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. | Approximately 43 Months |
| Time To Objective Response | 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. | Approximately 43 Months |
| Duration of Overall Response | 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. | Approximately 43 Months |
| Duration of Overall Complete Response | 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. | Approximately 43 Months |
| Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths | 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. | Approximately 43 Months |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center |
| Loma Linda |
| California |
| 92354 |
| United States |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Lombardi Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | United States |
| University of Florida Health Science Center - Jacksonville | Jacksonville | Florida | 32209 | United States |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536-0084 | United States |
| St. Louis University Hospital Cancer Center | St Louis | Missouri | 63110-0250 | United States |
| HemOnCare, P.C. | Brooklyn | New York | 11235 | United States |
| Lincoln Medical and Mental Health Center | The Bronx | New York | 10451 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Charleston Hematology-Oncology, P.A. | Charleston | South Carolina | 29403 | United States |
| Cancer Center at the University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98104 | United States |
| Rockwood Clinic P.S. | Spokane | Washington | 99202 | United States |
| West Virginia University Hospitals | Morgantown | West Virginia | 26506-9300 | United States |
| Carlini LE, Meropol NJ, Bever J, Andria ML, Hill T, Gold P, Rogatko A, Wang H, Blanchard RL. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res. 2005 Feb 1;11(3):1226-36. |
| FG001 | Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 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). |
| BG001 | Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0) | 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. | The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. | Posted | Number | percentage of participants | Approximately 43 Months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | 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. | The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. | Posted | Median | 95% Confidence Interval | months | Approximately 43 Months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | 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. | The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. | Posted | Median | 95% Confidence Interval | months | Approximately 43 Months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With One-year Survival | Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first. | The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Month 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | 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. | The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. | Posted | Median | 95% Confidence Interval | months | Approximately 43 Months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time To Objective Response | 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. | The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. | Posted | Median | 95% Confidence Interval | months | Approximately 43 Months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Overall Response | 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. | 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. | Posted | Median | 95% Confidence Interval | months | Approximately 43 Months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Overall Complete Response | 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. | 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. | Posted | Number | months | Approximately 43 Months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths | 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. | 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. | Posted | Number | Number of participants | Approximately 43 Months |
|
Approximately 43 Months
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 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). | 10 | 15 | 15 | 15 | ||
| EG001 | Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 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). | 25 | 52 | 52 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Ileitis | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Vasoconstriction | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 1.5 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 1.5 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Loose stools | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 1.5 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Candidiasis | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Herpes virus infection | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Nail bed infection | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 1.5 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 1.5 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 1.5 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 1.5 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 1.5 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 1.5 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 1.5 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 1.5 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 1.5 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 1.5 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 1.5 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 1.5 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 1.5 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 1.5 | Systematic Assessment |
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| Faecal occult blood positive | Investigations | MedDRA 1.5 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
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| Poor venous access | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
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| Phlebothrombosis | Vascular disorders | MedDRA 1.5 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 1.5 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 1.5 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 1.5 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 1.5 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 1.5 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 1.5 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 1.5 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 1.5 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 1.5 | Systematic Assessment |
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| Ear disorder | Ear and labyrinth disorders | MedDRA 1.5 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 1.5 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 1.5 | Systematic Assessment |
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| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 1.5 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
Not provided
Not provided
| Male |
|
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).
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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). |
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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).
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| OG001 | Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 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). |
| OG002 | Total Participants (Cohort 1 + Cohort 2) | Total of all reporting groups. |
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