G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients
- Conditions
- Small Cell Lung Cancer
- Registration Number
- NCT00401609
- Lead Sponsor
- National Cancer Institute, Naples
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- Histologic or cytologic diagnosis of SCLC
- Extensive disease
- Measurable disease
- Performance Status (ECOG) < o = 2
- Age > o = 70 years.
- Written informed consent.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations to evaluate activity and toxicity of GEMETO, GEMCAR, and GEMCIS combinations to evaluate activity and toxicity of GEMVIN combination
- Secondary Outcome Measures
Name Time Method treatment impact on patient quality of life clinical variables predictive of response to treatment prognostic value of ADL and IADL multidimensional geriatric evaluation scales
Trial Locations
- Locations (21)
Ospedale San Martino
🇮🇹Genova, GE, Italy
Divisione di Oncologia Medica, U.S.L.L. 13
🇮🇹Noale, VE, Italy
Ospedale Umberto di Frosinone
🇮🇹Frosinone, FR, Italy
Policlinico Universitario P. Giaccone
🇮🇹Palermo, PA, Italy
Policlinico Giaccone
🇮🇹Palermo, PA, Italy
Ospedale San Camillo - Forlanini
🇮🇹Rome, Italy
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
🇮🇹Monteforte Irpino, AV, Italy
Azienda Sanitaria Locale 2
🇮🇹Pozzuoli, Italy
Umberto I SS. Trinita' Ospedale
🇮🇹Frosinone, FR, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli
🇮🇹Roma, Italy
Ospedale Monaldi
🇮🇹Napoli, Italy
Istituto Regina Elena, Divisione di Oncologia Medica
🇮🇹Roma, 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 Serbelloni
🇮🇹Gorgonzola, MI, Italy
Istituto Oncologico Veneto
🇮🇹Padova, PD, Italy
Ospedale L. Sacco
🇮🇹Milano, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
🇮🇹Napoli, Italy
Ospedale Civile
🇮🇹Polla, SA, Italy
Ospedale La ferla
🇮🇹Palermo, PA, Italy