Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer (GEEP)
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|ClinicalTrials.gov Identifier: NCT00881296|
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : September 7, 2011
A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (> 75) with previously untreated advanced non-small cell lung cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (> 76 years) who have received no prior treatment for non-small lung cancer. As secondary objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin combination chemotherapy, progression-free survival and overall survival will be evaluated in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly single gemcitabine.
The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus carboplatin may improve the efficacy.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: gemcitabine and carboplatin Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||June 2011|
Gemcitabine 1000mg/m2 Day 1,15
Carboplatin AUC=3 Day 1, 15 every 4 weeks
Drug: gemcitabine and carboplatin
Gemcitabine 1000mg/m2, DIV on day 1 and 15 of each 28 day cycle. Carboplatin AUC=3, DIV on day 1 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles.
Active Comparator: 2
Gemcitabine 1000mg/m2 Day 1, 8, 15
Gemcitabine 1000mg/m2, DIV on day 1, 8 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles
- Efficacy (response rate) [ Time Frame: two-years, followed RECIST criteria ]
- The toxicity profile (adverse event profile) [ Time Frame: two-years, followed NCI-CTCAE criteria ]
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): NCT00881296
|Hamamatsu University School of Medicine|
|Hamamatsu, Shizuoka, Japan, 431-3192|
|Study Chair:||Kingo Chida, MD,PhD||Hamamatsu University|