Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00019773


Primary Contact:

Study Chair
Eva Szabo, MD
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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