Status and phase
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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:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
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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Hematopoietic
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PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Data sourced from clinicaltrials.gov
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