Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01085630|
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : March 5, 2019
Last Update Posted : August 18, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: pemetrexed disodium Other: clinical observation||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy|
|Actual Study Start Date :||April 2010|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||April 1, 2021|
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
- Progression-free Survival [ Time Frame: Baseline up to 3 years ]Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
- Overall Survival [ Time Frame: Baseline up to 3 years ]Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
- Response Rate [ Time Frame: Up to 3 years ]The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test
- Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) [ Time Frame: Baseline up to 3 years ]The number of patients reporting grade 3 or higher adverse events considered at least possibly related to study treatment as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.
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): NCT01085630
|Study Chair:||Arkadiusz Dudek, MD||Masonic Cancer Center, University of Minnesota|