G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the activity and toxicity of gemcitabine combined with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first line treatment of elderly patients with extensive small cell lung cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Histologic or cytologic diagnosis of SCLC

• Extensive disease

• Measurable disease

• Performance Status (ECOG) < o = 2

• Age > o = 70 years.

• Written informed consent.

Exclusion Criteria:

• Previous chemotherapy.

• Previous or concomitant malignancies (with the exception of adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix)

• •Neutrophils<2.000/mm3;platelets<100.000/mm3; hemoglobin < 10 g/dl

• Creatinine > 1.5 time the upper limit

• AST, ALT > 2.5 times and/or bilirubin > 1.5 time the upper limit of normal if liver metastases are absent or AST, ALT ³5 times and bilirubin > 3 times the upper limit of normal if liver metastases are present

• Symptomatic brain metastases