Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer.

PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.

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

Details

• Lead Sponsor: Velindre NHS Trust
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

DISEASE CHARACTERISTICS:

• Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell lung cancer) within the past 6 weeks

• No other intrathoracic tumors (e.g., carcinoid tumor, mesothelioma, lymphoma, or lung metastases from another primary site)

• No clinically apparent brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-3

• Platelet count ≥ 100,000/mm³

• Serum creatinine ≤ 150 µmol/L

• Willing and able to self-administer dalteparin by daily subcutaneous injection or have it administered by a caregiver

• Not pregnant or nursing

• Fertile female patients must use effective contraception (if sexually active)

• No hemorrhagic stroke within the past 3 months

• No known bleeding disorder

• No hemoptysis of CTC ≥ grade 2 (i.e., symptomatic hemoptysis requiring medical intervention)

• No central venous catheter requiring the use of thromboprophylaxis

• No known hypersensitivity to dalteparin, heparin, or other low molecular weight heparins (e.g., history of confirmed or suspected immunologically mediated heparin-induced thrombocytopenia; acute gastroduodenal ulcer; or subacute endocarditis)

• No prior illness likely to interfere with study treatment or comparisons

PRIOR CONCURRENT THERAPY:

• No prior treatment likely to interfere with study treatment or comparisons

• More than 12 months since prior and no concurrent therapeutic anticoagulation

• No concurrent ketorolac (Toradol®)