Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer|
- Overall Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
- Progression-free Survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
- Overall Survival (OS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]OS was measured from the date of study entry until the date of death.
|Study Start Date:||May 2005|
|Study Completion Date:||August 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
500mg/m2 IV over 10 min, Day 1, prior to gemcitabine
Other Name: AlimtaDrug: Gemcitabine
1500mg/m2, 30min IV
Other Name: Gemzar
Upon determination of eligibility, patients will be receive:
- Pemetrexed + Gemcitabine
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||David R. Spigel, MD||SCRI Development Innovations, LLC|