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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 |
Primary Objective:
1. 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:
Condition | Intervention | Phase |
Mesothelioma |
Drug: Cisplatin Drug: Imatinib Mesylate Drug: Pemetrexed |
Phase I |
MedlinePlus related topics: | Cancer Mesothelioma |
ChemIDplus related topics: | Cisplatin Imatinib Imatinib mesylate Pemetrexed disodium Pemetrexed |
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: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Cisplatin + Imatinib Mesylate + Pemetrexed
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Drug: Cisplatin
60 mg/m^2 IV Over 2 Hours
Drug: Imatinib Mesylate
300 mg PO Daily
Drug: Pemetrexed
500 mg/m^2 IV Over 40 Minutes
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Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
M.D. Anderson Cancer Center |
Novartis |
Principal Investigator: | Anne S. Tsao, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Anne S. Tsao, MD/Assistant Professor ) |
Study ID Numbers: | 2005-0288 |
First Received: | November 20, 2006 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00402766 |
Health Authority: | United States: Food and Drug Administration |
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