Clinical trial · Interventional
G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients
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
NCT00401609CI-TRIAL-00020526G-StepcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- 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 (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGridelli 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