Colorectal Cancer Clinical Trial
Official title:
Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with capecitabine
in treating patients who have colorectal, appendix, or small bowel cancer.
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of capecitabine when administered with
oxaliplatin in patients with colorectal, appendiceal, or small bowel cancer.
- Determine the clinical toxic effects associated with this regimen in these patients.
- Characterize the molecular profile of tumor tissue obtained prior to study entry for
determinants of sensitivity to this regimen in this patient population.
- Characterize the molecular profile of a surrogate normal tissue (bone marrow aspirate)
obtained prior to treatment and assess any potential drug-associated induction of DNA
damage and inhibition of thymidylate synthase with a repeat bone marrow aspirate during
therapy.
- Assess any clinical activity of this regimen in this patient population.
OUTLINE: This is a dose-escalation study of capecitabine.
Patients receive oxaliplatin IV over 2 hours on day 1 followed by oral capecitabine twice
daily on days 1-5 and 8-12. Courses repeat every 3 weeks in the absence of unacceptable
toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 6 months.
PROJECTED ACCRUAL: A total of 106 patients will be accrued for this study within 36 months.
;
Primary Purpose: Treatment
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