Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
The purpose of this multi-center Phase II trial is to examine the impact of pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and III non-squamous NSCLC. Because patients with non-squamous type NSCLC have been shown to have better survival rates than patients with squamous tumors when given pemetrexed with a platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and undifferentiated), not including squamous histology, will be allowed to participate in this study. If this novel regimen proves to be safe and active in this setting, it will provide rationale for further investigation in a larger, prospective, randomized trial.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer|
- Overall Survival at 3 Years [ Time Frame: 36 months ] [ Designated as safety issue: No ]Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, or death on study at 3 years.
- Objective tumor response [ Time Frame: At 6 and 12 weeks or until treatment discontinuation ] [ Designated as safety issue: No ]Defined as the sum of the longest diameter (LD) of all target lesions (baseline sum LD).
- Pathologic Tumor Response Rate [ Time Frame: At 6 and 12 weeks or until treatment discontinuation ] [ Designated as safety issue: No ]Determine the proportion of patients with complete or partial response (CR or PR) according to RECIST v1.0 criteria.
- Complete Resection Rate [ Time Frame: At 3-6 weeks following completion of 4-cycles of preoperative therapy ] [ Designated as safety issue: No ]Patients will be followed every 3 months during years 1 and 2, every 6 months during years 3-5, and annually thereafter for toxicity, disease progression and survival.
- Progression-Free Survival (PFS) [ Time Frame: At 6 and 12 weeks or until treatment discontinuation or death from any cause ] [ Designated as safety issue: No ]Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.0 criteria, or death on study.
- Overall Survival [ Time Frame: At 6 and 12 weeks or until treatment discontinuation or death from any cause ] [ Designated as safety issue: No ]Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.0, or death on study.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
4 cycles of preoperative treatment as follows:
Pemetrexed: 500 mg/m2 given intravenously (IV) over 10 minutes on Day 1 of every 21-day treatment cycle
Carboplatin: AUC=6 given IV on Day 1 of every 21-day treatment cycle
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week (21-day) treatment cycle for a total of 4 cycles (12 weeks).
Other Name: AlimtaDrug: Carboplatin
AUC=6 IV on Day 1 of every 3-week (21-day) treatment cycle for a total of 4 cycles (12 weeks).
Other Name: 41575-94-4
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906282
|United States, Florida|
|Florida Cancer Specialists|
|Fort Myers, Florida, United States, 33901|
|United States, Georgia|
|Medical Oncology Associates of Augusta|
|Augusta, Georgia, United States, 30901|
|Northeast Georgia Medical Center|
|Gainesville, Georgia, United States, 30501|
|United States, Kentucky|
|Baptist Hospital East|
|Louisville, Kentucky, United States, 40207|
|United States, Maryland|
|National Capital Clinical Research Consortium|
|Bethesda, Maryland, United States, 20817|
|Center for Cancer and Blood Disorders|
|Bethesda, Maryland, United States, 20817|
|United States, Nebraska|
|Nebraska Methodist Cancer Center|
|Omaha, Nebraska, United States, 68114|
|United States, Ohio|
|Oncology Hematology Care|
|Cincinnati, Ohio, United States, 45242|
|United States, South Carolina|
|South Carolina Oncology Associates, PA|
|Columbia, South Carolina, United States, 29210|
|United States, Tennessee|
|Chattanooga Oncology Hematology Associates|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|United States, Virginia|
|Virginia Cancer Institute|
|Richmond, Virginia, United States, 23235|
|Study Chair:||David R Spigel, M.D.||SCRI Development Innovations, LLC|