Status:
UNKNOWN
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
OBJECTIVES: Primary * Compare progression-free survival of patients with inoperable metastatic colorectal cancer treated with oxaliplatin, leucovorin calcium, and fluorouracil with vs without mainte...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00274872
Start Date
January 1 2004
Last Update
February 1 2010
Active Locations (17)
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1
Institut Sainte Catherine
Avignon, France, 84082
2
Hopital Duffaut
Avignon, France, 84902
3
Infirmerie Protestante
Caluire-et-Cuire, France, 69300
4
Hopital Drevon
Dijon, France, 21000