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

Tracking Information

First Received Date ^ICMJE

April 14, 2009

Last Updated Date

September 5, 2011

Start Date ^ICMJE

March 2008

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00881296 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer

Official Title ^ICMJE

Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-Small Cell Lung Cancer

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

76 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00881296

Other Study ID Numbers ^ICMJE

Hamamatsu 20-34

Has Data Monitoring Committee

Yes

Responsible Party

Naoki Inui, Hamamatsu University

Study Sponsor ^ICMJE

Hamamatsu University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Kingo Chida, MD,PhD

Hamamatsu University

Information Provided By

Hamamatsu University

Verification Date

May 2010

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

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