Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.

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

Details

• Lead Sponsor: Japan Clinical Oncology Group
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Bleomycin

Criteria

Inclusion Criteria:

• Pathologically documented lung cancer

• Clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary that it be documented by cytology)

• Expected to live 6 weeks or longer

• Sufficient organ function

• Signed informed consent

Exclusion Criteria:

• Myocardial infarction or unstable angina within 3 months

• Constrictive pericarditis

• Active pneumonitis

• Severe infection or disseminated intravascular coagulation (DIC)

• Other severe co-morbidity which could not be relieved with pericardial drainage

• Chemotherapy-naive small cell lung cancer