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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00881296
First received: April 14, 2009
Last updated: September 5, 2011
Last verified: May 2010
History of Changes
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
 Drug: gemcitabine and carboplatin
Drug: Gemcitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Hamamatsu University:

Primary Outcome Measures:
  • Efficacy (response rate) [ Time Frame: two-years, followed RECIST criteria ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The toxicity profile (adverse event profile) [ Time Frame: two-years, followed NCI-CTCAE criteria ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   76 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881296

Locations
Japan
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan, 431-3192
Sponsors and Collaborators
Hamamatsu University
Investigators
Study Chair: Kingo Chida, MD,PhD Hamamatsu University
  More Information

No publications provided by Hamamatsu University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Naoki Inui, Department of Respiratory Medicine, Hamamatsu University
ClinicalTrials.gov Identifier: NCT00881296     History of Changes
Other Study ID Numbers: Hamamatsu 20-34
Study First Received: April 14, 2009
Last Updated: September 5, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Hamamatsu University:
Elder Patients
Non-Small Cell Lung Cancer
Previously Untreated
Advanced

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 19, 2013