G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: vinorelbine
* Drug: cisplatin
* Drug: etoposide
* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine|nan|
|Drug: vinorelbine|nan|
|Drug: cisplatin|nan|
|Drug: etoposide|nan|
|Drug: carboplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate activity and toxicity of GEMVIN combination |  |  | 
| to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations |  |  | 
| to evaluate activity and toxicity of GEMETO, GEMCAR, and GEMCIS combinations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment impact on patient quality of life |  |  | 
| prognostic value of ADL and IADL multidimensional geriatric evaluation scales |  |  | 
| clinical variables predictive of response to treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly