Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas
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|ClinicalTrials.gov Identifier: NCT02838745|
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : March 4, 2020
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.
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: Pemetrexed Drug: Cisplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: Pemetrexed and Cisplatin
• Pemetrexed and cisplatin will be admixed together in 1 liter of normal saline. The admixture of pemetrexed/cisplatin is stable for 4 hours and should be prepared and delivered immediately before use in the OR. The length of the pemetrexed/cisplatin lavage will be 1 hour.
- Safety Maximum Tolerated Dose of HIOC with cisplatin and pemetrexed for Malignant Pleural Mesothelioma. [ Time Frame: 1 Month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838745
|Contact: Michelle G Almarez, BBA||713-798-3680||Michelle.Almarez@bcm.edu|
|Contact: Shawn Groth, MD||713-798-86281|