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

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT00401492
• Lead Sponsor: National Cancer Institute, Naples

Brief 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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2006-11-17
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-20
• Primary Completion: 2006-12
• Study Completion: 2007-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-12
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Histologic or cytologic diagnosis of NSCLC
• Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
• Age > o = 70 years.
• Written informed consent.

Exclusion Criteria

• Performance status (ECOG) ³2
• Previous chemotherapy.
• Symptomatic brain metastases requiring synchronous radiotherapy
• Previous radiotherapy (completed less than 4 weeks before enrollment)
• Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
• Neutrophils < 2.000/mm³ or platelets < 100.000/mm³ or hemoglobin < 10 g/dl.
• Serum creatinine > 1.5 times the UNL.
• GOT and/or GPT >1.25 times the UNL or serum total bilirubin >1.25 times the UNL without hepatic metastases.
• GOT and/or GPT >2.5 times the UNL or serum total bilirubin >1.5 times the UNL with hepatic metastases.
• Other concomitant diseases contraindicating the study treatments.
• Refusal of written informed consent.
• Follow-up impossible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine

Secondary Outcome Measures

Name	Time	Method
exploratory predictive clinical variables for chemotherapy related toxicity
exploratory predictive clinical variables for response to chemotherapy
patient quality of life
the prognostic significance of the ADL and IADL scales for time to progression and survival