Status:
UNKNOWN
Celecoxib, Leucovorin, Fluorouracil, and Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growt...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with metastatic colorectal cancer treated with celecoxib, leucovorin calcium, fluorouracil, and oxaliplatin. Secondary * Determine the...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic disease
- Inoperable disease (i.e., not suitable for complete carcinological surgical resection)
- Measurable disease or nonmeasurable disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional CT scan OR 10 mm by spiral CT scan
- Nonmeasurable disease defined as all other lesions, including small lesions or truly nonmeasurable disease
- No CNS metastases
- No exclusive bone metastases
- No symptomatic ascites or pleural effusion not evacuated before study entry
- PATIENT CHARACTERISTICS:
- Age
- 18 to 75
- Performance status
- WHO 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- No known significant bleeding disorder
- Hepatic
- Alkaline phosphatase less than 3 times upper limit of normal (ULN)
- Renal
- Creatinine less than 1.5 times ULN OR
- Creatinine clearance at least 30 mL/min
- No uncontrolled hypercalcemia
- Cardiovascular
- No congestive heart failure
- Gastrointestinal
- No total or partial bowel obstruction
- No active gastric or duodenal ulceration or gastrointestinal bleeding within the past year
- No active inflammatory bowel disease
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No peripheral sensory neuropathy
- No known sensitivity to celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides
- No AIDS-related illness
- No active infection
- No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior immunotherapy for metastatic disease
- Chemotherapy
- Prior adjuvant chemotherapy allowed provided the progression-free interval after completion of therapy is more than 6 months in duration
- No prior chemotherapy for metastatic disease
- No prior adjuvant oxaliplatin
- No other concurrent chemotherapy
- Endocrine therapy
- No concurrent chronic oral or IV corticosteroid use (i.e., 2 weeks or longer in duration)
- Radiotherapy
- No concurrent radiotherapy
- Surgery
- Not specified
- Other
- More than 30 days since prior investigational drugs
- No other concurrent investigational drugs or treatments
- No concurrent prophylactic fluconazole
- No concurrent chronic full-dose aspirin (at least 325 mg/day), other nonsteroidal anti-inflammatory drugs (NSAIDs), or other cyclooxygenase (COX)-2 inhibitors
- Concurrent low-dose (cardioprotective) aspirin (80 mg/day or equivalent) allowed
- No concurrent lithium
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072553
Start Date
September 1 2003
Last Update
February 9 2009
Active Locations (1)
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1
Hopital Tenon
Paris, France, 75970