drugset / Trial / NCT01243632
Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment
Phase 2
Completed
78 enrolled
Institute of Oncology Ljubljana
Ministry of Higher Education, Science and Technology, Solvenia · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2002-12
- Primary completion
- 2010-06
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 250 mg/m2 | — |