Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00906282|
Recruitment Status : Completed
First Posted : May 21, 2009
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Pemetrexed Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||September 2015|
4 cycles of preoperative treatment (1 Cycle = 21 days):
Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle; Carboplatin: AUC 6.0 by IV on Day 1 each cycle.
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Other Name: Alimta
AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Other Name: 41575-94-4
- 3-Year Overall Survival Rate [ Time Frame: 36 months ]The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause. Overall survival is shown for the Intent-to-Treat population.
- Objective Tumor Response [ Time Frame: At 6 and 12 weeks ]Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0. Patients with stable disease (SD) or response to treatment were deemed surgical candidates. [CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]
- Pathologic Response Rate [ Time Frame: weeks 15 -18 ]Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery. pCR defined as complete removal of all tumor. pPR defined as residual viable tumor demonstrated in the resected specimen.
- Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR) [ Time Frame: At 15-18 weeks ]pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).
- Complete Resection Rate [ Time Frame: At weeks 15-18 ]The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate. Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).
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): 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|
|Center for Cancer and Blood Disorders|
|Bethesda, Maryland, United States, 20817|
|National Capital Clinical Research Consortium|
|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|