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Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
This study is ongoing, but not recruiting participants.
First Received: March 8, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Cancer Research Campaign Clinical Trials Centre
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031863
  Purpose

RATIONALE: Rofecoxib may stop the growth of cancer by stopping blood flow to the tumor and killing tumor cells that remain after surgery. It is not yet known if rofecoxib is effective in treating colorectal cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of giving rofecoxib after surgery in treating patients who have stage II or stage III colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: rofecoxib
Procedure: adjuvant therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Official Title: Phase III, Randomized, Double Blind, Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031863

Locations
United Kingdom, England
Radcliffe Infirmary NHS Trust
Oxford, England, United Kingdom, OX2 6HE
Sponsors and Collaborators
Cancer Research Campaign Clinical Trials Centre
Investigators
Study Chair: David J. Kerr, MD, FRCP, DSc Oxford Radcliffe Hospitals NHS Trust
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069235, CRC-TU-VICTOR, EU-20054, CRC-TU-COX2, ISRCTN98278138, NCCTG-N004B
Study First Received: March 8, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00031863     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Rectal Diseases
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Digestive System Neoplasms
Cyclooxygenase Inhibitors
Adjuvants, Immunologic
Enzyme Inhibitors
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Analgesics, Non-Narcotic
Rofecoxib
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009