Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: gemcitabine and carboplatin; Drug: Gemcitabine

• Registration Number: NCT00881296
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Status Verified: 2010-05
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Last Update Submitted: 2011-09-05
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	gemcitabine and carboplatin	Gemcitabine 1000mg/m2 Day 1,15 Carboplatin AUC=3 Day 1, 15 every 4 weeks
2	Gemcitabine	Gemcitabine 1000mg/m2 Day 1, 8, 15

Primary Outcome Measures

Name	Time	Method
Efficacy (response rate)	two-years, followed RECIST criteria

Secondary Outcome Measures

Name	Time	Method
The toxicity profile (adverse event profile)	two-years, followed NCI-CTCAE criteria

Trial Locations

Locations (1)

Hamamatsu University School of Medicine; 🇯🇵 Hamamatsu, Shizuoka, Japan