Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Supportive care | Closed | 16 and over | Other | CRC-WARP EU-20049, NCT00024297 |
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.
Entry Criteria
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
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
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
Expected Enrollment
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.
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.
Trial Lead Organizations
Cancer Research UK Clinical Trials Unit - Birmingham
 | | | ||
| Annie Young, Protocol chair | |
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| Registry Information | ||
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| Official Title | A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis with Warfarin in Cancer Patients with Central Venous Catheters | |
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| Trial Start Date | 1999-10-19 | |
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| Registered in ClinicalTrials.gov | NCT00024297 | |
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| Date Submitted to PDQ | 2001-07-27 | |
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| Information Last Verified | 2002-12-05 | |
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.
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