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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Cisplatin; Gemcitabine; Vinorelbine

Criteria

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.