Heparin or Enoxaparin in Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004875
First received: March 7, 2000
Last updated: February 18, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004875

Locations
United States, Illinois
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, United States, 60611
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Northwestern University
Investigators
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
Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Thrombosis
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014