Trial | NCT00401609  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    85
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 Started
Nov 30
2000
Primary Completion
Dec 31
2007
Study Completion
Feb 28
2009
Last Update
Jan 14
2016
Estimate

Drug gemcitabine

Drug vinorelbine

Drug cisplatin

Drug etoposide

Drug carboplatin

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
No Results Posted