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

Phase 1CompletedNCT00019773

National Cancer Institute (NCI)

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Carcinoma of the Appendix Colorectal Cancer Small Intestine Cancer

Interventions

capecitabineDRUG

oxaliplatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

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