A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer
18 Years
75 Years
Both
Colorectal Cancer
Trial Information
A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer
OBJECTIVES:
- Compare the efficacy of different schedules of irinotecan in combination with
capecitabine as first-line therapy, in terms of objective response rate, in patients
with advanced or metastatic colorectal cancer.
- Compare the time to treatment failure, time to progression, and overall survival of
patients treated with these regimens.
- Compare the safety profile, in terms of toxicity, of these regimens in these patients.
- Determine the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
performance status (0 vs 1); disease symptoms, including pain, weight loss, loss of
appetite, malaise, and fever of unknown origin (yes vs no); weight loss during the past 6
months (more than 5% vs 5% or less); and disease-free interval (more than 6 months vs 6
months or less). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan IV over 1 hour on days 1, 8, 15, 22, and 29 and oral
capecitabine twice daily on days 1-14 and 22-35.
- Arm II: Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral
capecitabine as in arm I.
Treatment in both arms repeats every 6 weeks in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, and at the first visit
after treatment failure.
Patients are followed every 12 weeks for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per treatment arm) will be accrued for
this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced or metastatic colorectal cancer
- Unresectable disease
- At least 1 bidimensionally measurable lesion
- At least 2 cm in perpendicular diameters
- No evidence of CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- 0-1
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.25 times ULN
Cardiovascular:
- No clinically significant cardiac disease
- No congestive heart failure
- No New York Heart Association class III or IV heart disease
- No symptomatic coronary artery disease
- No uncontrolled cardiac arrhythmia
- No myocardial infarction within the past year
Gastrointestinal:
- No evidence of dysphagia
- No malabsorption or intestinal obstruction that would affect absorption or excretion
of study drugs
- No chronic diarrhea
Other:
- No other malignancy within the past 5 years except adequately treated carcinoma in
situ of the cervix or localized nonmelanoma skin cancer
- No psychiatric disability that would preclude study compliance
- No other significant medical condition
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for advanced or metastatic disease
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- At least 4 weeks since prior major surgery to the gastrointestinal tract
Other:
- No concurrent therapy for history of seizures or CNS disorder
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Markus M. Borner, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Inselspital, Berne
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 41/00
NCT ID:
NCT00030797
Start Date:
February 2001
Completion Date:
December 2003
Related Keywords:
- Colorectal Cancer
- stage III colon cancer
- stage IV colon cancer
- stage III rectal cancer
- stage IV rectal cancer
- Colorectal Neoplasms
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