Celecoxib Combined With Fluorouracil and Leucovorin in Treating Patients With Resected Stage III Adenocarcinoma (Cancer) of the Colon

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether fluorouracil and leucovorin are more effective with or without celecoxib in treating resected stage III adenocarcinoma (cancer) of the colon.

PURPOSE: This randomized phase III trial is studying celecoxib, fluorouracil, and leucovorin to see how well they work compared to fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Arbeitsgemeinschaft fur Internistische Onkologie; Dutch Colorectal Cancer Group (DCCG); EFCR - Egyptian foundation for Cancer Research; Egyptian Foundation For Cancer Research; EORTC GI Group (EORTC 40023); Federation Francophone de Cancerologie Digestive; GCCD-APIO - Grupo Cooperativo do Cancro Digestivo da Associação Portuguesa de Investigação; GOCCI - Gruppo Oncologico Chirurgico Cooperativo Italiano; GOIRC - Gruppo Oncologico Italiano di Ricerca Clinica; Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente; Oncológica; Onkologie; SG - Scandinavian Group; TTD - Grupo Español para el Tratamiento de Tumores Digestivos
• Treatments: Calcium; Celecoxib; Fluorouracil; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon

• 15 cm above anal verge

• Stage III disease (any pT, N1-2, M0)

• No rectal cancer

• Must have undergone curative radical resection (R0 resection) within the past 6 weeks

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• AST ≤ 5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• None of the following conditions within the past 6 months:

• Myocardial infarction

• Unstable angina

• Symptomatic congestive heart failure

• Serious uncontrolled cardiac arrhythmia

• Cerebrovascular accident or transient ischemic attack

• Deep vein thrombosis

• Other significant thromboembolic event

Pulmonary

• No pulmonary embolism within the past 6 months

Gastrointestinal

• No active gastric or duodenal ulceration within the past year

• No gastrointestinal bleeding within the past year

• No partial or complete bowel obstruction

• No known chronic malabsorption

• No active inflammatory bowel disease or chronic diarrhea (more than 4 stools/day)

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• HIV negative

• No AIDS-related illness

• No prior hypersensitivity to fluorouracil, leucovorin calcium, celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides

• No other severe acute or chronic medical condition or laboratory abnormality that would preclude study participation, study drug administration, or study results interpretation

• No psychological, familial, sociological, or geographical condition that would preclude study compliance

• No concurrent 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent sargramostim (GM-CSF) or molgramostim

Chemotherapy

• Not specified

Endocrine therapy

• No more than 4 weeks of concurrent orally/nasally inhaled steroids over a 6-month period

• Concurrent mometasone (or fluticasone) allowed if patients require ≥ 4 weeks of inhaled steroid therapy

• At least 30 days since other prior steroids

• No concurrent hormonal therapy

Radiotherapy

• No concurrent radiotherapy

Surgery

• See Disease Characteristics

• No prior total colectomy or other major surgery that would result in substantial alteration in transit to absorption of oral medication

Other

• More than 30 days since prior investigational medication

• No prior systemic anticancer treatment for colon cancer

• No concurrent prophylactic fluconazole

• No concurrent lithium

• No concurrent chronic* use of full dose aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or cyclo-oxygenase-2 (COX-2) inhibitors

• Aspirin at cardioprotective doses (i.e., 80 mg daily or equivalent) allowed

• No concurrent participation in any other clinical study

• No other concurrent experimental agents (e.g., other COX-2 inhibitors, matrix metalloproteinase inhibitors, inhibitors of the vascular endothelial growth factor/Flk-1 pathway, or inhibitors of the epidermal growth factor receptor pathway) NOTE: *Chronic use is defined as a frequency of 7 consecutive days (1 week) for more than 3 weeks/year or more than 21 days throughout the year