VICTOR

Post-treatment stage of a Phase III, randomised, double blind, placebo-controlled study of rofecoxib (VIOXX®) in colorectal cancer patients following potentially curative therapy.

EudraCT number: 2004-000657-39
Chief Investigator: Prof David J. Kerr
Sponsor: University of Oxford

The trial’s aim is to answer the question of whether VIOXX®, a potent orally active COX-2 inhibitor licensed for use in osteoarthritis, has a role as maintenance therapy in colorectal cancer patients following potentially curative therapy. Patients were randomised to receive VIOXX® or placebo (blinded), given for two or five years (not blinded) to address the question of optimum duration.

The VICTOR study opened on the 9th April 2002. The goal was to recruit 7000 patients over 5 years with 250 sites based in the UK, USA and Australia, with the study finally completing in 2012. On the 30th September 2004 the trial was closed to recruitment and all patients were taken off study drug, in response to the worldwide withdrawal of VIOXX® by Merck & Co. Inc. This was due to another study using VIOXX® (the APPROVe trial), which had found an increased relative risk of cardiovascular incidents in patients on VIOXX® for periods longer than 18 months. We are in the process of publishing a paper with a leading journal, which looks at the CV risk posed to the patients on the VICTOR trial.

STUDY STATUS

Closed to recruitment, in follow-up phase
Recruited number: 2434 patients
Follow up completing in December 2009.

Click <here> for list of participating sites

STUDY SCHEMA

INCLUSION CRITERIA

Histologically proven Dukes’ C (Stage III: any T, N1 2, M0) or B (Stage II: T3 or 4 N0, M0) colorectal carcinoma.
Patients must have undergone complete resection of the primary tumour without gross or microscopic evidence of residual disease.
WHO Performance Status 0 or 1.
Acceptable haematological and biochemical function. (Recommended values: Absolute neutrophil count < 1.5 x 109/L; platelets <100 x 109/L; creatinine clearance >30 ml/min; total bilirubin, AST/ALT < 1.5 times the upper limit of the normal range. It is recommended that tests are carried out <2 weeks prior to randomisation.).
Within 12 weeks of finishing potentially curative therapy (surgery alone, or surgery plus radiotherapy and/or chemotherapy).
Written informed consent given.

EXCLUSION CRITERIA

Patients with active peptic ulceration, upper GI bleed or patients with complicated ulcers (i.e. ulcers which have bled, perforated or caused obstruction) in the last year.
Patients with past history of adverse reaction to NSAIDs e.g. asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria.
Known sensitivity to VIOXX®.
Patients on long-term NSAID therapy (i.e. take NSAID > 3 times per week), except for low-dose* aspirin.
< 18 years of age.
Pregnant, lactating women or female patients not using adequate contraception.
Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years.
Patients with inflammatory bowel disease.
Patients with severe congestive heart failure.

*Low-dose aspirin is <100 mg/day

STUDY OBJECTIVES

Primary:

Treatment with VIOXX^®will result in improved overall survival compared with placebo.

Secondary:

Treatment with VIOXX^® will result in improved disease-free survival compared with placebo.

KEY DATES

Follow up completion: Dec 2009
Final analysis and publication: 2016
Trial duration: 7 years

Victor Trial Office (OCTO)

Randomisation Service Mon-Fri 9-5 (UK Time):

UK Tel: 0800 389 1635, UK Fax: 0800 389 1629 (24hrs)
Non UK Tel: +44 (0)1865 617 014, Non UK Fax: +44 (0)1865 617 015 (24hrs)

Enquiries:

Tel: +44 (0)1865 617 012, Fax: +44 (0)1865 617 010

Email: enquiries@victor-trial.co.uk
Website: www.octo-oxford.org.uk