G-Step: Gemcitabine Based Small-Cell Lung Cancer Treatment in Elderly Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 17, 2006

Last Updated Date

February 3, 2009

Start Date ^†

November 2000

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

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

Change History

Complete list of historical versions of study NCT00401609 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

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

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Small Cell Lung Cancer

Intervention ^†

Drug: gemcitabine
Drug: vinorelbine
Drug: cisplatin
Drug: etoposide
Drug: carboplatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

February 2009

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

70 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00401609

Responsible Party

Francesco Perrone, NCI Naples

Secondary IDs ^††

Study Sponsor ^†

National Cancer Institute, Naples

Collaborators ^††

Investigators ^†

Principal Investigator:	Cesare Gridelli, M.D.	San Giuseppe Moscati Hospital, Avellino, Italy
Principal Investigator:	Francesco Perrone, M.D., Ph.D.	National Cancer Institute Naples, Italy

Information Provided By

National Cancer Institute, Naples

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.