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

Small Cell Lung Cancer Clinical Trial

— G-Step  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401609
• Other study ID #: G-Step
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 17, 2006
• Last updated: January 13, 2016
• Start date: November 2000
• Est. completion date: February 2009

Study information

• Verified date: January 2016
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• gemcitabine

• vinorelbine

• cisplatin

• etoposide

• carboplatin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Gridelli C, Gallo C, Morabito A, Iaffaioli RV, Favaretto A, Isa L, Barbera S, Gamucci T, Ceribelli A, Filipazzi V, Maione P, Rossi A, Barletta E, Signoriello S, De Maio E, Piccirillo MC, Di Maio M, Rocco G, Vecchione A, Perrone F; G-STEP Investigators. Ph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate activity and toxicity of GEMVIN combination
Primary	to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations
Primary	to evaluate activity and toxicity of GEMETO, GEMCAR, and GEMCIS combinations
Secondary	treatment impact on patient quality of life
Secondary	prognostic value of ADL and IADL multidimensional geriatric evaluation scales
Secondary	clinical variables predictive of response to treatment