Pemetrexed and Gemcitabine in Patients With Advanced 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: 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|
|Actual Primary Completion Date :||December 2008|
|Actual 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.
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): NCT00193414
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||David R. Spigel, MD||SCRI Development Innovations, LLC|