NCT00401492

MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer

Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer

Detailed description

The study design includes three parallel phase II studies, all with the same rules for patient selection and outcome assessment. In the two studies of cisplatin-based doublets, a dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing doses of cisplatin (50-60-70 mg/m²). Following this phase, patients will be assigned to the three studies through a randomization procedure, to reduce selection biases. Arm A: gemcitabine: Gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 \& 8 of each cycle, every 21 days, for a maximum of 6 cycles. Arm B: cisplatin + vinorelbine: Vinorelbine 25 mg/m² on days 1 \& 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles. Arm C: cisplatin + gemcitabine: Gemcitabine 1000 mg/m2,, on days 1 \& 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine prolonged continuous infusion
DRUG	cisplatin
DRUG	vinorelbine

Timeline

• Start date: 2002-06-01
• Primary completion: 2006-12-01
• Completion: 2007-04-01
• First posted: 2006-11-20
• Last updated: 2012-07-13