Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC

Study Overview
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Brief Summary
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The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.

Detailed Description
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About 50% of newly diagnosed cases of NSCLC concern patients older than 65 years, while 30-40% of cases are diagnosed in patients older than 70 years. Furthermore, recent data suggest that during the last decade, the incidence and mortality of NSCLC has decreased in younger patients, while it has increased among older patients. Based on these observations, it becomes clear that NSCLC represents a significant health problem in elderly patients. However, elderly patients are frequently underrepresented in clinical trials evaluating new treatments in NSCLC. Indeed, more than 75% of patients older than 65 years with metastatic NSCLC never receive any kind of chemotherapy in the daily clinical practice. In elderly patients there is lack of prospective data regarding the role of platinum-based doublets. It is not clear whether elderly patients gain any survival benefit or not from platinum-based doublets and whether these chemotherapeutic regimens result in a significant increase in toxicity. There is a clear need to prospectively evaluate the tolerability and efficacy of platinum-based doublets as first-line chemotherapy for older NSCLC patients. On this basis it would be very interesting to initiate a phase I/II study with gemcitabine/carboplatin combination as first line treatment in older NSCLC patients.

Official Title
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A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC.

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥70 years old Cytologically or histologically documented NSCLC Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion) World Health Organisation (WHO) performance status 0-2 Non-frail patients according to Comprehensive Geriatric Assessment Previously treated NSCLC (or patients for whom the combination is considered adequate treatment) (for phase I part) No prior chemotherapy (for phase II part) Life expectancy of at least 12 weeks Serum bilirubin less than 1.5 times the upper normal limit Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance >60 ml/min Neutrophil count more than 1.5x 109 /L Platelet count more than 100x 109 /L Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations. Exclusion Criteria: Hemoptysis Central nervous system metastases Clinically significant cardiovascular disease Medically uncontrolled hypertension Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ) Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbo/GEM<br> | Drug: Carboplatin<br>* Carboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks<br>Drug: Gemcitabine<br>* Gemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate |  | Disease evaluation at Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate | Disease control rate is defined as the proportion of patients with complete response or partial response or stable disease for at least 16 weeks | Disease evaluation at Week 8 | 
| Progression Free Survival |  | 1 year | 
| Overall Survival |  | 1 year | 
| Safety Profile | Patients will be evaluated for Adverse Events (related or unrelated to the treatment) on Day 1 of each cycle (cycle repeated every 2 weeks) up to 12 weeks from the date of first dose administration | Every two weeks up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic NSCLC, Elderly, 1st Line, Platinum-based treatment