Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma
| Sponsored by: | M.D. Anderson Cancer Center |
| Information provided: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00402766 |
Purpose:
Primary Objective: - To determine the maximum tolerated dose of the combination of cisplatin, imatinib mesylate, and pemetrexed in metastatic malignant mesothelioma. Secondary Objectives: - 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 | Intervention | Phase |
|
Mesothelioma |
Drug: Cisplatin Drug: Imatinib Mesylate Drug: Pemetrexed |
Phase 1 |
Eligibility
Study Design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Official Title: Phase I Trial of Cisplatin, Pemetrexed, and Imatinib Mesylate in Unresectable or Metastatic Malignant Mesothelioma
Enrollment Size: Both
Gender: 18 Years
Min. Age: N/A
Max. Age: No
Location and Contact Information
United States, Texas
UT MD Anderson Cancer Center, Houston, Texas, 77030, United States
Status:
Last modified: July 29 2010.
