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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Capecitabine; Oxaliplatin

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