Official Title: “A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters”

RATIONALE: Warfarin may be effective in preventing the formation of blood clots in patients with central venous catheters.

PURPOSE: Randomized clinical trial to study the effectiveness of warfarin in preventing blood clots in cancer patients who have central venous catheters.

Study Type: Interventional

Study Design: Supportive Care

OBJECTIVES: - Determine the utility of warfarin in reducing thrombosis rates in cancer patients with central venous catheters. - Compare the thrombosis rates in patients treated with different warfarin dosing schedules. - Compare the adverse events and survival of patients receiving or not receiving this drug.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sclerosant potential of cytotoxic regimen (low vs high), site of placement of catheter (peripheral vs central), and duration of drug administration (brief infusion (under 24 hours) vs prolonged infusion (24 hours and over)). Patients are randomized to 1 of 3 arms. - Arm I: Patients receive no warfarin. - Arm II: Patients receive oral warfarin daily beginning 3 days before placement of central venous catheter (CVC) and continuing until CVC is removed or thrombosis occurs. - Arm III: Patients receive oral warfarin as in arm II, with dose adjustment after CVC placement to achieve and maintain INR level.

Patients are followed at 12 months.

PROJECTED ACCRUAL: A total of 1,400 patients (400 in arm I, 700 in arm II, and 300 in arm III) will be accrued for this study within 2 years.

Intervention(s) in this Clinical Trial

• Drug: warfarin

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed cancer
• Planned placement of central venous catheter (CVC) for administration of chemotherapy
• No use of CVC for additional purposes except for antibiotic therapy or blood products

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 2,000/mm3
• Platelet count at least 100,000/mm3
• Hemoglobin at least 10 g/dL
• No congenital bleeding disorders

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No contraindication to warfarin
• No anatomic lesions that bleed (e.g., duodenal ulcers)
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• Biologic therapy
• Not specified
• Chemotherapy
• See Disease Characteristics
• Endocrine therapy
• Not specified
• Radiotherapy
• Not specified
• Surgery
• Not specified
• Other
• No prior enrollment on this study
• No concurrent therapy that would interfere with study drug
• No concurrent warfarin

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cancer Research Campaign Clinical Trials Centre

Overall Clinical Trial Officials and Contacts

Annie Young Study Chair University Hospital Birmingham  

Information obtained from ClinicalTrials.gov on January 06, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00024297

Study ID Number: CDR0000068909

ClinicalTrials.gov Identifier: NCT00024297

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database