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

Sponsored by:	National Cancer Institute, Naples
Information provided by:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT00401609

Purpose

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.

Condition	Intervention	Phase
Small Cell Lung Cancer	Drug: gemcitabine Drug: vinorelbine Drug: cisplatin Drug: etoposide Drug: carboplatin	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Carboplatin Vinorelbine Gemcitabine Gemcitabine hydrochloride Vinorelbine tartrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute, Naples:

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

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

Estimated Enrollment:	85
Study Start Date:	November 2000
Study Completion Date:	February 2009
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401609

Locations

Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131
Ospedale L. Sacco
Milano, Italy
Ospedale San Camillo - Forlanini
Rome, Italy
Ospedale Monaldi
Napoli, Italy
Azienda Sanitaria Locale 2
Pozzuoli, Italy
Istituto Regina Elena, Divisione di Oncologia Medica
Roma, Italy, 00144
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, Italy, 00186
Italy, AV
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
Italy, BA
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
Italy, CB
Ospedale A. Cardarelli
Campobasso, CB, Italy, 86100
Italy, CS
Ospedale Mariano Santo, U.O. di Oncologia Medica
Cosenza, CS, Italy, 87100
Italy, FR
Ospedale Umberto di Frosinone
Frosinone, FR, Italy, 03031
Umberto I SS. Trinita' Ospedale
Frosinone, FR, Italy
Italy, GE
Ospedale San Martino
Genova, GE, Italy
Italy, MI
Ospedale Serbelloni
Gorgonzola, MI, Italy
Italy, PA
Policlinico Universitario P. Giaccone
Palermo, PA, Italy, 90100
Ospedale La ferla
Palermo, PA, Italy
Policlinico Giaccone
Palermo, PA, Italy
Italy, PD
Istituto Oncologico Veneto
Padova, PD, Italy
Italy, SA
Ospedale Civile
Polla, SA, Italy
Italy, VE
Divisione di Oncologia Medica, U.S.L.L. 13
.Noale, VE, Italy, 30033

Sponsors and Collaborators

National Cancer Institute, Naples

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

More Information

No publications provided

Responsible Party:	NCI Naples ( Francesco Perrone )
Study ID Numbers:	G-Step
Study First Received:	November 17, 2006
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00401609 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:

elderly

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Carcinoma, Neuroendocrine
Immunologic Factors
Etoposide phosphate
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Gemcitabine
Etoposide

Carboplatin
Antiviral Agents
Immunosuppressive Agents
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Vinorelbine
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Carcinoma, Neuroendocrine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal

Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 03, 2009