Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma
|ClinicalTrials.gov Identifier: NCT00402766|
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : November 18, 2015
- To determine the maximum tolerated dose of the combination of cisplatin, imatinib mesylate, and pemetrexed in metastatic malignant mesothelioma.
- To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor tissue by:
- histologic analysis of biopsy tissue
- by non-invasive assessments of tumor vascularity performed before, during and after treatment
- electron microscopy analysis of endothelial cell architecture after patient treatment with imatinib mesylate
- To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate markers in serum.
- To assess the rate of response to therapy.
- To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor (PDGF-R) on malignant mesothelioma tumor cells.
- To determine the pharmacokinetic interaction between agents in this combination regimen.
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: Cisplatin Drug: Imatinib Mesylate Drug: Pemetrexed Drug: Dexamethasone||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Cisplatin, Pemetrexed, and Imatinib Mesylate in Unresectable or Metastatic Malignant Mesothelioma|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Cisplatin + Imatinib + Pemetrexed
Cisplatin 60 mg/m^2 by vein, Over 2 Hours. Imatinib 300 mg PO Daily. Pemetrexed 500 mg/m^2 by vein, Over 40 Minutes. Dexamethasone 20 mg by vein given prior to Pemetrexed therapy and 4 mg given orally on Day 2 of each cycle.
Starting Dose: 60 mg/m^2 by vein, Over 2 Hours
Other Names:Drug: Imatinib Mesylate
Starting Dose: 300 mg PO Daily
Other Names:Drug: Pemetrexed
Starting Dose: 500 mg/m^2 by vein, Over 40 Minutes
Other Names:Drug: Dexamethasone
20 mg by vein given prior to Pemetrexed therapy and 4 mg given orally on Day 2 of each cycle.
Other Name: Decadron
- Maximum Tolerated Dose (MTD) of Cisplatin, Pemetrexed, and Imatinib Mesylate Given to Participants with Unresectable or Metastatic Malignant Mesothelioma [ Time Frame: After six cycles of 28 day cycles, up 6 months ]MTD defined as the highest dose level in which 6 patients have been treated with less than or equal to 2 instances of dose limiting toxicity (DLT). DLT characterized by the National Cancer Institute (NCI) Common Toxicity Criteria. DLT defined as (1) febrile neutropenia (fever > grade 2 with grade 4 neutropenia and requiring IV antibiotics); (2) grade 4 neutropenia (ANC < 500/mL) for more than seven days duration; (3) grade 4 thrombocytopenia; (4) grade 3 or 4 non-hematologic toxicity (except alopecia).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402766
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anne S. Tsao, MD||M.D. Anderson Cancer Center|