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

National Cancer Institute, Naples

Status and phase

Completed

Phase 2

Phase 1

Conditions

Small Cell Lung Cancer

Treatments

Drug: etoposide

Drug: cisplatin

Drug: gemcitabine

Drug: vinorelbine

Drug: carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00401609

G-Step

Details and patient eligibility

About

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.

Full description

Four treatment arms are planned.

GEMVIN: gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on days 1 & 8, every 21 days
GEMCAR: gemcitabine 1000 on days 1 & 8 and carboplatin AUC 3.5 or 4 or 4.5 on day 1, every 21 days
GEMCIS: gemcitabine 1000 mg/m2 on days 1 & 8 and cisplatin 50 or 60 or 70 mg/m2 on day 1, every 21 days
GEMETO: gemcitabine 1000 mg/m2 on days 1 & 8 and etoposide 60 or 70 or 80 mg/m2 on days 1,2,3 every 21 days

For the study of the GEMVIN combination a two-stage minimax flexible design will be applied. For the remaining 3 combinations (GEMCAR, GEMCIS, GEMETO) a phase 1/2 design aimed at looking for optimal dose within a Bayesian framework will be applied.

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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