Clinical trial NCT00401609: G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Keywords: elderly
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2006-11-20
Enrollment: 85
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: to evaluate activity and toxicity of GEMVIN combination
measure: to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations
measure: to evaluate activity and toxicity of GEMETO, GEMCAR, and GEMCIS combinations
Secondary outcomes:
measure: treatment impact on patient quality of life
measure: prognostic value of ADL and IADL multidimensional geriatric evaluation scales
measure: clinical variables predictive of response to treatment
Other outcomes:
Locations:
city: Monteforte Irpino
country: Italy
facility: Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
state: AV
city: Bari
country: Italy
facility: IRCCS Oncologico Bari, Oncologia Medica
state: BA
city: Campobasso
country: Italy
facility: Ospedale A. Cardarelli
state: CB
city: Cosenza
country: Italy
facility: Ospedale Mariano Santo, U.O. di Oncologia Medica
state: CS
city: Frosinone
country: Italy
facility: Ospedale Umberto di Frosinone
state: FR
city: Frosinone
country: Italy
facility: Umberto I SS. Trinita' Ospedale
state: FR
city: Genova
country: Italy
facility: Ospedale San Martino
state: GE
city: Gorgonzola
country: Italy
facility: Ospedale Serbelloni
state: MI
city: Palermo
country: Italy
facility: Policlinico Universitario P. Giaccone
state: PA
city: Palermo
country: Italy
facility: Ospedale La ferla
state: PA
city: Palermo
country: Italy
facility: Policlinico Giaccone
state: PA
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: PD
city: Polla
country: Italy
facility: Ospedale Civile
state: SA
city: Noale
country: Italy
facility: Divisione di Oncologia Medica, U.S.L.L. 13
state: VE
city: Milano
country: Italy
facility: Ospedale L. Sacco
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
city: Napoli
country: Italy
facility: Ospedale Monaldi
city: Pozzuoli
country: Italy
facility: Azienda Sanitaria Locale 2
city: Roma
country: Italy
facility: Istituto Regina Elena, Divisione di Oncologia Medica
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli
city: Rome
country: Italy
facility: Ospedale San Camillo - Forlanini
Study officials:
affiliation: San Giuseppe Moscati Hospital, Avellino, Italy
name: Cesare Gridelli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute Naples, Italy
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.