RATIONALE: Heparin or enoxaparin may be effective in preventing the formation of blood clots in patients with cancer who are undergoing surgery to remove the tumor.

PURPOSE: Randomized clinical trial to compare the effectiveness of heparin with that of enoxaparin in patients who have cancer.

Condition	Treatment or Intervention
Lymphoma	Drug: enoxaparin  Drug: heparin

Further Study Details: 

OBJECTIVES: I. Determine the patterns of tissue factor pathway inhibitor (TFPI) release according to tumor type and type of anticoagulation (heparin or enoxaparin) in patients with cancer.

II. Determine the incidence of portacath clots and its correlation to TFPI releasability in this patient population.

III. Compare these anticoagulation drugs in terms of releasability of TFPI in this patient population.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to prior chemotherapy within the past 3 weeks (yes vs no). Patients are randomized to one of two treatment arms.

Arm I: Patients receive a single dose of standard heparin subcutaneously (SQ) followed by evaluation of tissue factor pathway inhibitor (TFPI) response at 5 and 10 minutes post injection.

Arm II: Patients receive a single dose of enoxaparin SQ followed by evaluation of TFPI response as in arm I.

Patients are followed monthly for 3 months.

PROJECTED ACCRUAL: A total of 20-200 patients will be accrued for this study over 6 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven malignancy, including lymphomas
• No leukemias

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Concurrent chemotherapy allowed
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: At least 1 month since prior eye, spinal cord, or CNS surgery
• Other: At least 1 day since prior heparin or enoxaparin; At least 1 week since prior therapeutic coumadin (prior prophylactic coumadin allowed); No other concurrent anticoagulants

--Patient Characteristics--

• Age: 18 and over
• Performance status: Not specified
• Life expectancy: Greater than 6 months
• Hematopoietic: Hemoglobin greater than 8.5 g/dL; Platelet count greater than 100,000/mm3; No history of heparin and/or low weight molecular heparin induced thrombocytopenia; No history of bleeding diathesis
• Hepatic: No history of coagulation factor deficiency; No hepatic encephalopathy; No hepatic failure; No cirrhosis; No hemophilia
• Renal: Creatinine less than 2.5 mg/dL (no greater than upper limit of normal for diabetes mellitus)
• Cardiovascular: No New York Heart Association class III or IV heart disease; No congestive heart failure; No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mmHg and diastolic blood pressure at least 110 mmHg); No endocarditis; No hemorrhagic stroke; No prior or concurrent deep vein thrombosis
• Pulmonary: No prior or concurrent pulmonary embolus
• Other: No known allergy to enoxaparin or standard heparin; No known allergy to fish (e.g., protamine sulfate) or swine products; No active ulcerative disease or angiodysplasia of the gastrointestinal (GI) tract or active GI bleeding within the past 6 months; No other active significant medical illness or major failure of any organ system; No refusal of donor blood products secondary to religious or other reasons; Not pregnant or nursing

Illinois
      Evanston Northwestern Health Care, Evanston,  Illinois,  60201,  United States
      Veterans Affairs Medical Center - Chicago (Lakeside), Chicago,  Illinois,  60611,  United States

Study chairs or principal investigators

Hau C. Kwaan,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067535; NU-96X2; NCI-G00-1670
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004875
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08