Celecoxib, Leucovorin, Fluorouracil, and Oxaliplatin 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, 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 growth of colorectal cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining celecoxib with leucovorin, fluorouracil, and oxaliplatin in treating patients who have metastatic colorectal cancer.

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

Details

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

Criteria

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