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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carcinoma of the Appendix, Colorectal Cancer, Small Intestine Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed colorectal, appendiceal, or small bowel cancer Measurable disease No progression after prior capecitabine No brain metastases or leptomeningeal carcinomatosis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal Creatinine clearance greater than 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No sensory neuropathy No history of allergy to platinum compounds No history of allergy to antiemetics appropriate for administration during study No history of intolerance to fluorouracil No uncontrolled concurrent illness that would preclude study entry No ongoing or active infection requiring IV antibiotics HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy No more than 2 prior systemic chemotherapy regimens for metastatic disease At least 6 weeks since prior nitrosoureas or mitomycin At least 8 weeks since prior eniluracil At least 3 months since prior suramin At least 4 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy At least 2 weeks since prior radiotherapy to no more than 20% of bone marrow reserve At least 4 weeks since prior radiotherapy to at least 21% of bone marrow reserve Surgery: Recovered from prior surgery Other: At least 4 weeks since prior sorivudine or brivudine and recovered No concurrent sorivudine or brivudine No other concurrent investigational agents No other concurrent anticancer therapy or commercial agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage 0 colon cancer, stage 0 rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, small intestine adenocarcinoma, small intestine lymphoma, small intestine leiomyosarcoma, recurrent small intestine cancer, carcinoma of the appendix