Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Warfarin for Prevention of the Development of a Blood Clot in Patients With Cancer Who Have a Central Venous Access Catheter

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed over 18 NCI CCCWFU-97194 NCI-P95-0064

Objectives

I.  Determine whether warfarin prevents thrombosis in central venous access 
catheters (CVAC) and prolongs their accessibility and usefulness in cancer 
patients.

II.  Compare the incidence of CVAC failure in patients treated with warfarin 
vs. placebo.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Prior/Concurrent Therapy:

No active anticoagulation therapy at the time of CVAC insertion, e.g., heparin
or warfarin

No concurrent vitamin K supplementation

Concurrent aspirin or nonsteroidal anti-inflammatory agents allowed

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients over 18 about to undergo placement of their first central venous
access catheter (CVAC) for treatment of any histologically documented cancer
(solid tumor, leukemia, or lymphoma)
  No prior central venous line
  Prior coronary arteriography or balloon angioplasty allowed

No contraindication to anticoagulation therapy:
  No known intolerance to warfarin
  No severe liver disease causing hypoprothrombinemia
  No bleeding diathesis caused by congenital deficiency of factors VIII, IX,
     X, V, VII, XI, or II
  No serious active bleeding sites (e.g., gastrointestinal or genitourinary 
     tract)

Thrombocytopenia allowed

Emaciated patients undergoing radiotherapy eligible

Effective contraception required of fertile women

--Prior/Concurrent Therapy--

No active anticoagulation therapy at the time of CVAC insertion, e.g., heparin
or warfarin

No concurrent vitamin K supplementation

Concurrent aspirin or nonsteroidal anti-inflammatory agents allowed

Expected Enrollment

Up to 400 patients will be entered to obtain 362 evaluable patients.  Duration 
of study is 2 years.

Outline

Randomized, double-blind study.

Arm I:  Anticoagulant Therapy.  Warfarin, NSC-59813.

Arm II:  Control.  Placebo, PLCB.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

John Owen, MD, FRCPC, FIBMS, Protocol chair(Contact information may not be current)		Ph: 336-716-4464; 800-446-2255