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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Florida Cancer Specialists
Fort Myers, Florida, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Baptist Hospital East
Louisville, Kentucky, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
National Capital Clinical Research Consortium
Bethesda, Maryland, United States
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
...and 2 more locations
3-Year Overall Survival Rate
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.
Time frame: 36 months
Objective Tumor Response
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. \[CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.\]
Time frame: At 6 and 12 weeks
Pathologic Response Rate
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.
Time frame: weeks 15 -18
Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)
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).
Time frame: At 15-18 weeks
Complete Resection Rate
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).
Time frame: At weeks 15-18
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