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

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: NCT00881296
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : September 7, 2011
Sponsor:
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1

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
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




Primary Outcome Measures :
  1. Efficacy (response rate) [ Time Frame: two-years, followed RECIST criteria ]

Secondary Outcome Measures :
  1. The toxicity profile (adverse event profile) [ Time Frame: two-years, followed NCI-CTCAE criteria ]


Information from the National Library of Medicine

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Ages Eligible for Study:   76 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Japan
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan, 431-3192
Sponsors and Collaborators
Hamamatsu University
Investigators
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Study Chair: Kingo Chida, MD,PhD Hamamatsu University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Naoki Inui, Department of Respiratory Medicine, Hamamatsu University
ClinicalTrials.gov Identifier: NCT00881296    
Other Study ID Numbers: Hamamatsu 20-34
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: May 2010
Keywords provided by Naoki Inui, Hamamatsu University:
Elder Patients
Non-Small Cell Lung Cancer
Previously Untreated
Advanced
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Carboplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs