Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in mesothelioma patients. However, median survival of this patient group was only about 12 months. With intent to find more effective treatment the investigators performed phase II study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore such regiment in patients with malignant pleural mesothelioma (MPM) as well.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Oncology Ljubljana
• Collaborator: Ministry of Higher Education, Science and Technology, Solvenia
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Biopsy-proven diagnosis of malignant pleural mesothelioma

• Inoperable for anatomic or physiological reason

• Measurable and previously unirradiated lesion

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2

• Adequate haematopoietic, liver, and kidney function.

• Signed informed consent for participation in the trial

Exclusion Criteria:

• Significant medical co-morbidity

• Pregnant or lactating women

• History of the cancer in the previous 10 years or breast cancer ever.