Phase III, Randomized, Double Blind, Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy
18 Years
N/A
Both
Colorectal Cancer
Trial Information
Phase III, Randomized, Double Blind, Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy
OBJECTIVES:
- Compare the overall survival of patients with previously resected stage II or III
colorectal cancer treated with rofecoxib vs placebo administered for at least 2 years
vs 5 years.
- Compare the relapse-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients
are stratified according to participating center, site of disease (colon vs rectum), disease
stage (II vs III), age, adjuvant chemotherapy (yes vs no), and type of chemotherapy regimen
(1 vs 2 vs 3 vs 4 vs 5). Within 3 months of surgical resection alone or completion of
adjuvant radiotherapy and/or chemotherapy after surgical resection, patients are randomized
to one of four treatment arms.
- Arm I: Patients receive oral rofecoxib once daily for 2 years.
- Arm II: Patients receive oral rofecoxib once daily for 5 years.
- Arm III: Patients receive oral placebo once daily for 2 years.
- Arm IV: Patients receive oral placebo once daily for 5 years. Treatment continues in
all arms in the absence of disease recurrence or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 7,000 patients (1,750 per treatment arm) will be accrued for
this study within 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal carcinoma
- Stage II (T3-4, N0, M0) or stage III (any T, N1-2, M0) disease
- Completely resected primary tumor without gross or microscopic evidence of residual
disease
- Must have received potentially curative therapy within the past 12 weeks, including
any of the following:
- Surgery alone
- Surgery plus radiotherapy and/or chemotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 1.5 times ULN
Renal:
- Creatinine clearance greater than 30 mL/min
Cardiovascular:
- No severe congestive heart failure
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active peptic ulcer or gastrointestinal bleeding within the past year
- No inflammatory bowel disease
- No known sensitivity to rofecoxib
- No prior adverse reaction to non-steroidal anti-inflammatory drugs (NSAIDs) (e.g.,
asthma, acute rhinitis, nasal polyps, angioneurotic edema, or urticaria)
- No other malignancy within the past 10 years except adequately treated carcinoma in
situ of the cervix or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Other:
- No concurrent long-term NSAIDs except low-dose aspirin (no more than 80 mg/day) for
cardio-prophylaxis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
David J. Kerr, MD, FRCP, DSc
Investigator Role:
Study Chair
Investigator Affiliation:
Oxford University Hospitals NHS Trust
Authority:
United States: Federal Government
Study ID:
CDR0000069235
NCT ID:
NCT00031863
Start Date:
February 2001
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage II colon cancer
- stage III colon cancer
- stage II rectal cancer
- stage III rectal cancer
- Colorectal Neoplasms
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