A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots, also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can occasionally be life-threatening. The purpose of this study is to determine if a daily injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the frequency of blood clots. Dalteparin is currently approved for prevention of blood clots following surgery and in hospitalized patients but not specifically for cancer outpatients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborators: Eisai Inc.; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• A histologic diagnosis of malignancy;

• At planned initiation of a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen);

• A risk score for VTE ≥3 [assign score of 2 for very high risk sites of cancer (stomach, pancreas), score of 1 for high risk site (lung, lymphoma, gynecologic, bladder, testicular) and score of 0 for all other sites], hemoglobin <10 g/dL or planned use of erythropoiesis stimulating agents, platelet count ≥350,000/mm3, total leukocyte count > 11,000/mm3 or body mass index ≥ 35 kg/m2]. Any counts meeting criteria drawn within 2 weeks prior to enrollment are considered acceptable.

• Age 18 years or older

• Provide written, informed consent.

Exclusion Criteria:

• Active bleeding or at high risk of serious bleeding complication in the opinion of the investigator

• Diagnosis of primary brain tumor multiple myeloma, leukemia, or myelodysplastic syndrome

• Planned stem cell transplant

• Life expectancy < 6 months

• Known allergy to heparin or LMWH

• Patient or caregiver incapable of daily self-injection

• Acute or chronic renal insufficiency with creatinine clearance < 30 mL/min

• History of heparin-induced thrombocytopenia

• Allergy to contrast agents

• Pregnancy

• Need for anticoagulant therapy

• Platelet count < 75,000/mm3