G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients
NCT ID: NCT00401609
Last Updated: 2016-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
85 participants
INTERVENTIONAL
2000-11-30
2009-02-28
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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gemcitabine
vinorelbine
cisplatin
etoposide
carboplatin
Eligibility Criteria
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Inclusion Criteria
* Extensive disease
* Measurable disease
* Performance Status (ECOG) \< o = 2
* Age \> o = 70 years.
* Written informed consent.
Exclusion Criteria
* 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
70 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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NCI Naples
Principal Investigators
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Cesare Gridelli, M.D.
Role: PRINCIPAL_INVESTIGATOR
San Giuseppe Moscati Hospital, Avellino, Italy
Francesco Perrone, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute Naples, Italy
Locations
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Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, 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
Policlinico Universitario P. Giaccone
Palermo, PA, Italy
Ospedale La ferla
Palermo, PA, Italy
Policlinico Giaccone
Palermo, PA, Italy
Istituto Oncologico Veneto
Padua, PD, Italy
Istituto Regina Elena, Divisione di Oncologia Medica
Roma, Roma, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, Roma, Italy
Ospedale Civile
Polla, SA, Italy
Divisione di Oncologia Medica, U.S.L.L. 13
Noale, VE, Italy
Ospedale L. Sacco
Milan, , Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, , Italy
Ospedale Monaldi
Napoli, , Italy
Azienda Sanitaria Locale 2
Pozzuoli, , Italy
Ospedale San Camillo - Forlanini
Rome, , Italy
Countries
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References
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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.
Other Identifiers
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G-Step
Identifier Type: -
Identifier Source: org_study_id
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