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

Sponsor

National Cancer Institute, Naples (Other)

Overall Status

Completed

CT.gov ID

NCT00401609

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: gemcitabine Drug: vinorelbine Drug: cisplatin Drug: etoposide Drug: carboplatin	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2000

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Feb 1, 2009

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica	Monteforte Irpino	AV	Italy	83024
2	IRCCS Oncologico Bari, Oncologia Medica	Bari	BA	Italy	70126
3	Ospedale A. Cardarelli	Campobasso	CB	Italy	86100
4	Ospedale Mariano Santo, U.O. di Oncologia Medica	Cosenza	CS	Italy	87100
5	Ospedale Umberto di Frosinone	Frosinone	FR	Italy	03031
6	Umberto I SS. Trinita' Ospedale	Frosinone	FR	Italy
7	Ospedale San Martino	Genova	GE	Italy
8	Ospedale Serbelloni	Gorgonzola	MI	Italy
9	Policlinico Universitario P. Giaccone	Palermo	PA	Italy	90100
10	Ospedale La ferla	Palermo	PA	Italy
11	Policlinico Giaccone	Palermo	PA	Italy
12	Istituto Oncologico Veneto	Padova	PD	Italy
13	Ospedale Civile	Polla	SA	Italy
14	Divisione di Oncologia Medica, U.S.L.L. 13	Noale	VE	Italy	30033
15	Ospedale L. Sacco	Milano		Italy
16	Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B	Napoli		Italy	80131
17	Ospedale Monaldi	Napoli		Italy
18	Azienda Sanitaria Locale 2	Pozzuoli		Italy
19	Istituto Regina Elena, Divisione di Oncologia Medica	Roma		Italy	00144
20	Ospedale S. Giovanni Calibita Fatebenefratelli	Roma		Italy	00186
21	Ospedale San Camillo - Forlanini	Rome		Italy

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