Oxaliplatin Plus Capecitabine in Treating Patients With Colorectal, Appendix, or Small Bowel Cancer
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|ClinicalTrials.gov Identifier: NCT00019773|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma of the Appendix Colorectal Cancer Small Intestine Cancer||Drug: capecitabine Drug: oxaliplatin||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients|
|Study Start Date :||July 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019773
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Eva Szabo, MD||National Cancer Institute (NCI)|