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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00402766 |
Purpose
Primary Objective:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Mesothelioma |
Drug: Cisplatin Drug: Imatinib Mesylate Drug: Pemetrexed |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I Trial of Cisplatin, Pemetrexed, and Imatinib Mesylate in Unresectable or Metastatic Malignant Mesothelioma |
| Estimated Enrollment: | 42 |
| Study Start Date: | August 2006 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Cisplatin + Imatinib Mesylate + Pemetrexed
|
Drug: Cisplatin
60 mg/m^2 by vein, Over 2 Hours
Drug: Imatinib Mesylate
300 mg PO Daily
Drug: Pemetrexed
500 mg/m^2 by vein, Over 40 Minutes
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pts must have adequate hepatic,renal,& bone marrow function,defined as the following:
Exclusion Criteria:
Contacts and Locations| Contact: Anne S. Tsao, MD | 713-792-6363 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Anne S. Tsao, MD | |
| Principal Investigator: | Anne S. Tsao, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Anne S. Tsao, MD/Assistant Professor ) |
| Study ID Numbers: | 2005-0288 |
| Study First Received: | November 20, 2006 |
| Last Updated: | May 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00402766 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Mesothelioma Pleural Mesothelioma Peritoneal Mesothelioma PDGF-R Pemetrexed Alimta Cisplatin Imatinib Mesylate Gleevec |
Platinol Platinol-AQ CDDP Ly231514 Multitargeted Antifolate NSC-698037 STI571 NSSC-716051 |
|
Antimetabolites Folate Folic Acid Antagonists Folinic Acid Protein Kinase Inhibitors Vitamin B9 Imatinib |
Pemetrexed Folic Acid Cisplatin Radiation-Sensitizing Agents Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |
|
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Folic Acid Antagonists Protein Kinase Inhibitors |
Pharmacologic Actions Pemetrexed Imatinib Neoplasms Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |