Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.
Drug: pemetrexed disodium
Other: clinical observation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy|
- Progression-free survival [ Time Frame: Baseline up to 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Baseline up to 3 years ] [ Designated as safety issue: No ]
- Frequency of responses [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Baseline up to 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: pemetrexed disodium
Other Name: 150399-23-8
Active Comparator: Arm II
Patients undergo observation until disease progression.
|Other: clinical observation|
- To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin.
- To determine the overall survival of patients treated with this regimen versus observation.
- To evaluate the frequency of responses in patients treated with this regimen.
- To assess the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium), histologic subtype (epithelioid vs other) and number of courses received (< 6 vs 6).
- Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085630
|Contact: Arkadiusz Dudek, MD||312-413-8878|
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|Study Chair:||Arkadiusz Dudek, MD||Masonic Cancer Center, University of Minnesota|