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

National Cancer Institute, Naples85 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Cancer

Interventions

gemcitabineDRUG

vinorelbineDRUG

cisplatinDRUG

etoposideDRUG

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (21)

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

Monteforte Irpino, AV, Italy

IRCCS Oncologico Bari, Oncologia Medica

Bari, BA, Italy

Outcomes

Primary Outcomes

to evaluate activity and toxicity of GEMVIN combination

to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations

to evaluate activity and toxicity of GEMETO, GEMCAR, and GEMCIS combinations

Secondary Outcomes

treatment impact on patient quality of life

prognostic value of ADL and IADL multidimensional geriatric evaluation scales

clinical variables predictive of response to treatment

Data from ClinicalTrials.gov

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