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About
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.
Full description
OBJECTIVES:
Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer. Compare the progression-free survival of patients treated with these regimens. Compare the tolerability of these regimens in these patients. Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1. Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months for 1 year.
Patients are followed at 2 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal carcinoma
Not amenable to surgery
Unidimensionally measurable disease
No bone metastases
No brain metastases
PATIENT CHARACTERISTICS:
Age
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Life expectancy
Hematopoietic
Hepatic
Renal
Cardiac
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Data sourced from clinicaltrials.gov
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