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

Evaluation of Activity and Toxicity of Polychemotherapy With 2-drug Combinations Containing Gemcitabine as First Line Treatment of Elderly Patients With Small Cell Lung Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00401609

Acronym

G-Step

Enrollment

Registered

2006-11-20

Start date

2000-11-30

Completion date

2009-02-28

Last updated

2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

elderly

Brief 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.

Detailed 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.

Interventions

DRUGgemcitabine

DRUGvinorelbine

DRUGcisplatin

DRUGetoposide

DRUGcarboplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
treatment impact on patient quality of life	—
prognostic value of ADL and IADL multidimensional geriatric evaluation scales	—
clinical variables predictive of response to treatment	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026