Status:
COMPLETED
G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE1
PHASE2
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 e...
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 ...
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis of SCLC
- Extensive disease
- Measurable disease
- Performance Status (ECOG) \< o = 2
- Age \> o = 70 years.
- Written informed consent.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
February 1 2009
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00401609
Start Date
November 1 2000
End Date
February 1 2009
Last Update
January 14 2016
Active Locations (21)
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1
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
2
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
3
Ospedale A. Cardarelli
Campobasso, CB, Italy, 86100
4
Ospedale Mariano Santo, U.O. di Oncologia Medica
Cosenza, CS, Italy, 87100