Overview

Combination Chemotherapy 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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Treatments:
Calcium
Fluorouracil
Irinotecan
Leucovorin
Levoleucovorin
Oxaliplatin
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the colon or
rectum Measurable or evaluable lesion or residual disease (e.g., ascites, bone metastases)
Failure after first line therapy Fluorouracil and leucovorin calcium OR Raltitrexed No
oxaliplatin or irinotecan Relapse within 6 months of adjuvant therapy Relapse within 6
months of hepatic artery infusion chemotherapy for resected hepatic metastasis No
symptomatic brain metastasis

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hepatic: AST and
ALT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater
than 5 times ULN Renal: Not specified Other: No bowel obstruction No other significant,
uncontrolled underlying medical or psychiatric condition No serious active infection
Neurologically stable No other prior malignancy except nonmelanomatous skin cancer or
carcinoma in situ of the cervix No psychological, social, familial, or geographical
condition that would preclude study Not pregnant or nursing Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior
radiotherapy Surgery: At least 2 weeks since prior surgery Other: No other concurrent
experimental drugs