Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM
Summary
Primary Objective To determine the maximum tolerated dose (MTD) of intrathoracic administration of pemetrexed when given in conjunction with cisplatin in patients with resectable malignant pleural mesothelioma MPM. Secondary Objectives To determine the toxicity and grades associated with cytoreductive surgery and Hyperthermic Intraoperative Chemotherapy HIOC with cisplatin and pemetrexed in patients with resectable MPM. To assess overall survival and progression-free survival after PD or EPP and HIOC with cisplatin and pemetrexed for MPM Correlative Objectives To characterize the pharmacokinetics and pharmacodynamics of pemetrexed when administered as a hyperthermic intrathoracic lavage after PD or EPP To determine whether the degree of thymidylate synthase and ERCC1 gene expression in MPM tissue correlates with clinical response to pemetrexed.
Timeline
- Start
- 2016-09
- Primary completion
- 2019-09-05
- Completion
- 2019-09-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 175 mg/m2 | Other |
| Subject | Pemetrexed | Small molecule | 300 mg/m2 | Other |
| Subject | Pemetrexed | Small molecule | 400 mg/m2 | Other |