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Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer (GEEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00881296
First Posted: April 15, 2009
Last Update Posted: September 7, 2011
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.
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University
April 14, 2009
April 15, 2009
September 7, 2011
March 2008
March 2011   (Final data collection date for primary outcome measure)
Efficacy (response rate) [ Time Frame: two-years, followed RECIST criteria ]
Same as current
Complete list of historical versions of study NCT00881296 on ClinicalTrials.gov Archive Site
The toxicity profile (adverse event profile) [ Time Frame: two-years, followed NCI-CTCAE criteria ]
Same as current
Not Provided
Not Provided
 
Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer
Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • 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.
  • Drug: Gemcitabine
    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
  • Experimental: 1

    Gemcitabine 1000mg/m2 Day 1,15

    Carboplatin AUC=3 Day 1, 15 every 4 weeks

    Intervention: Drug: gemcitabine and carboplatin
  • Active Comparator: 2
    Gemcitabine 1000mg/m2 Day 1, 8, 15
    Intervention: Drug: Gemcitabine
Kusagaya H, Inui N, Karayama M, Nakamura Y, Kuroishi S, Yokomura K, Toyoshima M, Shirai T, Masuda M, Yamada T, Yasuda K, Suda T, Chida K. Biweekly combination therapy with gemcitabine and carboplatin compared with gemcitabine monotherapy in elderly patients with advanced non-small-cell lung cancer: a randomized, phase-II study. Lung Cancer. 2012 Sep;77(3):550-5. doi: 10.1016/j.lungcan.2012.05.106. Epub 2012 Jun 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
  • Good performance status (ECOG 0-1)
  • No previous treatment
  • Age 76 years and older
  • Adequate bone marrow, liver and renal functions
  • No pregnant
  • Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as >=1.0 cm by spiral CT scan
  • Provided written informed consent

Exclusion Criteria:

  • Severe complications or a concomitant malignancy
  • Prior and other concurrent radiotherapy, chemotherapy, immunotherapy, EGFR tyrosine kinase inhibitors
  • Interstitial pneumonia or lung fibrosis
  • Contraindicated gemcitabine or carboplatin
  • Inappropriate patients for entry to this study, judged by the physicians
Sexes Eligible for Study: All
76 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00881296
Hamamatsu 20-34
Yes
Not Provided
Not Provided
Naoki Inui, Hamamatsu University
Hamamatsu University
Not Provided
Study Chair: Kingo Chida, MD,PhD Hamamatsu University
Hamamatsu University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP