Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma
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|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|
|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
Drug: Imatinib Mesylate
Starting Dose: 300 mg PO Daily
Starting Dose: 500 mg/m^2 by vein, Over 40 Minutes
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).
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): 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|