NCT00019773

Oxaliplatin Plus Capecitabine in Treating Patients With Colorectal, Appendix, or Small Bowel Cancer

Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Carcinoma of the Appendix
• Colorectal Cancer
• Small Intestine Cancer

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	oxaliplatin

Timeline

• Start date: 1999-07-01
• First posted: 2003-01-27
• Last updated: 2015-04-29

Locations

1 site across 1 country: United States