Phase III Randomized Adjuvant Study of Rofecoxib in Patients With Previously Resected Stage II or III Colorectal Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

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Alternate Title

Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overOtherCRC-TU-VICTOR
EU-20054, CRC-TU-COX2, ISRCTN98278138, NCCTG-N004B, NCT00031863

Objectives

  1. 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.
  2. Compare the relapse-free survival of patients treated with these regimens.

Entry 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

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

Patient Characteristics:

    Age:

  • 18 and over

    Performance status:

  • WHO 0-1

    Life expectancy:

  • Not specified

    Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

    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

Expected Enrollment

A total of 7,000 patients (1,750 per treatment arm) will be accrued for this study within 5 years.

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.

Published Results

Midgley RS, McConkey CC, Johnstone EC, et al.: Phase III randomized trial assessing rofecoxib in the adjuvant setting of colorectal cancer: final results of the VICTOR trial. J Clin Oncol 28 (30): 4575-80, 2010.[PUBMED Abstract]

Kerr DJ, Dunn JA, Langman MJ, et al.: Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer. N Engl J Med 357 (4): 360-9, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Clinical Trials Unit - Birmingham

David Kerr, MD, FRCP, DSc, Protocol chair
Ph: 44-1865-224-482
Email: david.kerr@clinpharm.ox.ac.uk

Registry Information

Official TitlePhase III, Randomized, Double Blind, Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy
Trial Start Date2001-02-01
Registered in ClinicalTrials.govNCT00031863
Date Submitted to PDQ2002-01-16
Information Last Verified2002-06-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.