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

NCT00401609 | Completed Phase 1

• 1 other identifier: G-Step
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 21

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.

Conditions

Small Cell Lung Cancer

Keywords

elderly

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• treatment impact on patient quality of life

• prognostic value of ADL and IADL multidimensional geriatric evaluation scales

• clinical variables predictive of response to treatment

Interventions

gemcitabine DRUG

vinorelbine DRUG

cisplatin DRUG

etoposide DRUG

carboplatin DRUG

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologic or cytologic diagnosis of SCLC
• Extensive disease
• Measurable disease
• Performance Status (ECOG) \< o = 2
• Age \> o = 70 years.
• Written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (21)

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

Monteforte Irpino, AV, 83024, Italy

Location

IRCCS Oncologico Bari, Oncologia Medica

Bari, BA, 70126, Italy

Location

Ospedale A. Cardarelli

Campobasso, CB, 86100, Italy

Location

Ospedale Mariano Santo, U.O. di Oncologia Medica

Cosenza, CS, 87100, Italy

Location

Ospedale Umberto di Frosinone

Frosinone, FR, 03031, Italy

Location

Umberto I SS. Trinita' Ospedale

Frosinone, FR, Italy

Location

Ospedale San Martino

Genova, GE, Italy

Location

Ospedale Serbelloni

Gorgonzola, MI, Italy

Location

Policlinico Universitario P. Giaccone

Palermo, PA, 90100, Italy

Location

Ospedale La ferla

Palermo, PA, Italy

Location

Policlinico Giaccone

Palermo, PA, Italy

Location

Istituto Oncologico Veneto

Padua, PD, Italy

Location

Istituto Regina Elena, Divisione di Oncologia Medica

Roma, Roma, 00144, Italy

Location

Ospedale S. Giovanni Calibita Fatebenefratelli

Roma, Roma, 00186, Italy

Location

Ospedale Civile

Polla, SA, Italy

Location

Divisione di Oncologia Medica, U.S.L.L. 13

Noale, VE, 30033, Italy

Location

Ospedale L. Sacco

Milan, Italy

Location

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, 80131, Italy

Location

Ospedale Monaldi

Napoli, Italy

Location

Azienda Sanitaria Locale 2

Pozzuoli, Italy

Location

Ospedale San Camillo - Forlanini

Rome, Italy

Location

Related 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. Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: the G-STEP trial. J Thorac Oncol. 2012 Jan;7(1):233-42. doi: 10.1097/JTO.0b013e318233d6c2.

  PMID: 22031232 RESULT

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Gemcitabine; Vinorelbine; Cisplatin; Etoposide; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes

Study Officials

• Cesare Gridelli, M.D.

  San Giuseppe Moscati Hospital, Avellino, Italy

  PRINCIPAL INVESTIGATOR

• Francesco Perrone, M.D., Ph.D.

  National Cancer Institute Naples, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 20, 2006
• Study Start: November 1, 2000
• Primary Completion: December 1, 2007
• Study Completion: February 1, 2009
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

IT (21)