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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed over 18 DMS-8308 NCI-V87-0190

Objectives

I.  Determine the safety and tolerance of combined warfarin/RA-233 in patients 
with advanced cancer for whom there is no satisfactory conventional therapy.
II.  Observe patients for evidence of activity of this combined drug therapy 
against the neoplasm.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients more than 18 years of age 
with a pathologic diagnosis of cancer for whom no other chemotherapy, 
radiotherapy, or surgery available is of proven efficacy.  At least 3 weeks 
must have elapsed since the most recent chemotherapy and/or radiotherapy 
treatment, and patients must have recovered from the acute toxicities of 
previous treatment.  No anticoagulant drugs such as heparin or warfarin may 
have been given in the 2 weeks prior to study entry.  A projected survival of 
at least 2 months and a performance status of 0, 1, 2, or 3 are required, as 
are a neutrophil count of greater than 1,000/cumm, platelets greater than 
50,000/cumm, prothrombin time less than 16 seconds, and serum creatinine no 
more than 1.5 mg%.  There may be no evidence of hepatic decompensation on any 
basis other than malignancy; patients with florid ascites, jaundice, portal 
hypertension, or coma are excluded, but patients with elevated SGOT, GGT, and 
alkaline phosphatase secondary to malignant disease are eligible.  The 
following conditions exclude:  evidence of infection, active bleeding, or any 
symptom or sign (radiologic or endoscopic) of peptic ulcer in the last 6 
months; history of hereditary hemorrhagic disorders; history of allergy or 
idiosyncratic reaction to RA-233, dipyridamole, or warfarin; pregnancy; 
advanced cardiac disease (New York Heart Association classification III or 
greater); or simultaneous medical or psychiatric illness preventing compliance 
with treatment or adequate followup.

Expected Enrollment

20 patients will be entered over an estimated 12 months.

Outline

Nonrandomized study.
2-Drug Combination Chemotherapy.  Warfarin, NSC-59813; Mopidamol, RA-233.

Trial Contact Information

Trial Lead Organizations

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Leo Zacharski, MD, Protocol chair		Ph: 802-296-5149