Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

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

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven adenocarcinoma of the colon or rectum

• Metastatic disease

• No metastases involving only the bone

• Inoperable disease (i.e., not suitable for complete surgical resection)

• Measurable or evaluable disease

• Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan

• No symptomatic ascites or pleural effusion that has not been evacuated

• No CNS metastasis

PATIENT CHARACTERISTICS:

• WHO OR ECOG performance status 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelets ≥ 100,000/mm^3

• Creatinine < 3 times upper limit of normal (ULN)

• Alkaline phosphatase < 5 times ULN

• No peripheral neuropathy ≥ grade 1

• No total or partial bowel obstruction

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No uncontrolled hypercalcemia

• No other concurrent or prior malignancy, except adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin or cancer in complete remission for ≥ 5 years

• No uncontrolled congestive heart failure

• No angina pectoris

• No hypertension

• No arrhythmias

• No history of significant neurologic or psychiatric disorders

• No active infection

• No other serious nonmalignant disease

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy and/or immunotherapy for metastatic disease

• Prior adjuvant chemotherapy allowed provided progression-free interval after completion of adjuvant chemotherapy is > 6 months

• No other concurrent anticancer treatment

• No participation in another clinical trial with any investigational drug within 30 days prior to randomization

• No other concurrent investigational treatment

• No concurrent radiotherapy

• No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention of stomatitis