Overview

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.