Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00193414|
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 13, 2012
Last Update Posted : November 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Pemetrexed Drug: Gemcitabine||Phase 2|
Upon determination of eligibility, patients will be receive:
- Pemetrexed + Gemcitabine
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||May 2005|
|Primary Completion Date :||December 2008|
|Study Completion Date :||August 2009|
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
- Overall Response Rate [ Time Frame: 18 months ]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 ]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 ]OS was measured from the date of study entry until the date of death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193414
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||David R. Spigel, MD||SCRI Development Innovations, LLC|