Capecitabine, Irinotecan, and Oxaliplatin in Treating Patients With Metastatic Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin in treating patients with metastatic cancer.

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

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Treatments: Camptothecin; Capecitabine; Irinotecan; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically confirmed metastatic carcinoma

• Primary tumor may be present

• No curative therapy available or the patient achieved no response to prior standard therapy

• Nonresectable metastatic disease

• Measurable, evaluable, or nonevaluable disease

Exclusion criteria:

• Symptomatic brain metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Inclusion criteria:

• WHO performance status 0-2

• Life expectancy ≥ 12 weeks

• ANC ≥ 2,000/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 10 g/dL

• Bilirubin < 1.25 times upper limit of normal (ULN) (1.5 times ULN if due to liver metastases)

• Transaminases < 3 times ULN (5 times ULN if due to liver metastases)

• Alkaline phosphatase ≤ 3 times ULN

• Creatinine ≤ 1.5 times ULN

• Creatinine clearance > 30 mL/min

• Not pregnant or nursing

• Fertile patients must use effective contraception

Exclusion criteria:

• Severe concurrent infection or major organ failure, including any of the following:

• Cardiac disease

• Diabetic decompensation

• Clinically active infection

• Prior severe toxicity from fluorouracil

• Intestinal obstruction or subobstruction

• Malabsorption syndrome

• Peripheral neuropathy

• Uncontrolled epilepsy

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• At least 4-6 weeks since prior anticancer chemotherapy

Exclusions criteria:

• Prior chemotherapy with any of the study drugs

• Prior major intestinal resection

• Concurrent participation in another clinical study