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

Hamamatsu University

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: gemcitabine and carboplatin; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00881296

Hamamatsu 20-34

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 76+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

Gemcitabine 1000mg/m2 Day 1,15 Carboplatin AUC=3 Day 1, 15 every 4 weeks

Treatment:

Drug: gemcitabine and carboplatin

2

Active Comparator group

Description:

Gemcitabine 1000mg/m2 Day 1, 8, 15

Treatment:

Drug: Gemcitabine