Heparin or Enoxaparin in Patients With Cancer
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Purpose
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 | Intervention |
|---|---|
|
Lymphoma Thromboembolism Unspecified Adult Solid Tumor, Protocol Specific |
Drug: enoxaparin Drug: heparin |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Release of TFPI by Anticoagulants in Cancer Patients by Standard or LMW Heparin |
| Enrollment: | 6 |
| Study Start Date: | July 1996 |
| Study Completion Date: | March 1999 |
| Primary Completion Date: | March 1999 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Standard Heparin | Drug: heparin |
| Enoxaprin | Drug: enoxaparin |
Detailed Description:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
A group of cancer patients representing a large variety of different tumor types will be observed after receiving standard heparin or enoxaprin to determine risk for thromboembolic disease.
DISEASE CHARACTERISTICS: Histologically proven malignancy, including lymphomas No leukemias
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
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
Contacts and Locations| United States, Illinois | |
| Veterans Affairs Medical Center - Chicago (Lakeside) | |
| Chicago, Illinois, United States, 60611 | |
| Evanston Northwestern Health Care | |
| Evanston, Illinois, United States, 60201 | |
| Study Chair: | Hau C. Kwaan, MD | Veterans Affairs Medical Center - Lakeside Chicago |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hau C. Kwaan MD, PhD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004875 History of Changes |
| Other Study ID Numbers: | NU 96X2, NU-96X2, NCI-G00-1670 |
| Study First Received: | March 7, 2000 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma unspecified adult solid tumor, protocol specific stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage I adult diffuse small cleaved cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage I adult Burkitt lymphoma stage III grade 1 follicular lymphoma |
stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult Burkitt lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Thromboembolism Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Thrombosis Calcium heparin Heparin Enoxaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013