Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Gemcitabine 1000mg/m2 Day 1,15

Carboplatin AUC=3 Day 1, 15 every 4 weeks

Group Type EXPERIMENTAL

gemcitabine and carboplatin

Intervention Type DRUG

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.

2

Gemcitabine 1000mg/m2 Day 1, 8, 15

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No