Comparing Two Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

• Status: Unknown status
• 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. It is not yet known which regimen of combination chemotherapy is more effective for metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic colorectal cancer.

• Phase: 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 confirmed unresectable metastatic adenocarcinoma of the colon or rectum

• Bidimensionally measurable or evaluable disease outside previously irradiated area

• No bone metastasis as target lesion

• At least 1 cm if spiral CT scan OR

• At least 2 cm if conventional CT scan

• No CNS metastasis

• No symptomatic ascites or pleural effusion that is not evacuated

• No total or partial bowel obstruction

PATIENT CHARACTERISTICS:

Age:

• 18 to 80

Performance status:

• ECOG 0-2

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Alkaline phosphatase less than 5 times upper limit of normal (ULN)

Renal:

• Creatinine less than 3 times ULN

• No uncontrolled hypercalcemia

Cardiovascular:

• No uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmias

Other:

• No peripheral sensory neuropathy

• No prior significant neurologic or psychiatric disorders

• No other malignancy within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma

• No active infection

• No other concurrent serious disease

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy for metastatic disease

Chemotherapy:

• Prior adjuvant chemotherapy allowed, provided progression-free interval of more than 6 months since end of last course

• No prior oxaliplatin or irinotecan

• No prior chemotherapy for metastatic disease

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No concurrent radiotherapy

Surgery:

• Concurrent surgery allowed

Other:

• At least 30 days since other prior investigational drugs

• No other concurrent investigational treatment

• No other concurrent antitumoral treatment