Docetaxel Plus Bevacizumab 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 efficacy and safety of the combination of Docetaxel plus Bevacizumab in a Phase 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. According to retrospective data,the addition of bevacizumab to a standard, platinum-based chemotherapy regimen improves overall survival in patients with advanced non-squamous-cell, non-small-cell lung cancer and a good ECOG performance status. In addition, bevacizumab prolongs progression-free survival and improves response rate. In elderly patients there is a complete lack of prospective data regarding the role of bevacizumab. It is not clear whether elderly patients gain any survival benefit or not and if the addition of bevacizumab to standard chemotherapeutic regimens results in a significant increase in toxicity. There is a clear need to prospectively evaluate the tolerability of bevacizumab when added to standard first-line chemotherapy of elderly NSCLC patients. Therefore, the investigators propose to study the efficacy in elderly (>70 years) patients treated with cytotoxic chemotherapy in combination with bevacizumab in the context of 1st line treatment.

Official Title
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First Line Treatment of Elderly Patients With Advanced or Metastatic NSCLC With Docetaxel and Bevacizumab

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Bevacizumab


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 No prior chemotherapy 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 Hemorrhagic diathesis or coagulopathy Anticoagulation therapy; regular use of aspirin (>325 mg/d), nonsteroidal anti-inflammatory agents, or other agents known to inhibit platelet function Major surgery within 28 days before enrolment Clinically significant cardiovascular disease Medically uncontrolled hypertension Radiological evidence of tumors invading or abutting major blood vessels 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doc/Bev<br>Docetaxel/Bevacizumab | Drug: Docetaxel<br>* Docetaxel: 60mg/m2 i.v on day 1. Cycle repeated ever 3 weeks<br>Drug: Bevacizumab<br>* Bevacizumab: 7.5 mg/kg, iv on day 1. Cycle repeated every 3 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 9 | 

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 9 | 
| 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 3 weeks) up to 18 weeks from the date of first dose administration | Every three weeks up to 18 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, Bevacizumab-based treatment