Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)

Study Overview
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Brief Summary
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Despite recent advances in the treatment of NSCLC overall survival within these patients remains dismal and there is yet an unmet medical need for additional treatment options. In this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and bevacizumab) is tested to determine the objective response rate in patients with unresectable and advanced non-small cell lung cancer. This response rate will be compared with historical data.

Official Title
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Phase II Study to Investigate the Treatment of Patients With NSCLC Stage IIIB and IV Without the Option of Surgery With a Combination of Cisplatin, Docetaxel and Bevacizumab

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Cisplatin
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically documented inoperable, locally advanced, metastatic or recurrent NSCLC other than squamous cell At least 1 measurable lesion according to RECIST criteria ECOG performance score 0 or 1 Age between 18 and 70 years Exclusion Criteria: Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component. History of haemoptysis Evidence of tumour invading major blood vessels on imaging. Previous neoadjuvant/adjuvant chemotherapy. Previous radiotherapy. Serious uncontrolled coagulation disorder or thrombo-embolic complications within 6 months prior to study start or history of serious bleeding complications. Major surgical procedures within 4 weeks prior to study entry. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion. Non-healing wound, active peptic ulcer or bone fracture. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum 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

| Intervention/Treatment |
| --- |
|Drug: Bevacizumab|3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging -> further 3 cycles BCD Q3W -> Bevacizumab Q3W until progression|
|Drug: Cisplatin|3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging -> further 3 cycles BCD Q3W|
|Drug: Docetaxel|3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging -> further 3 cycles BCD Q3W|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | The primary objective of this proof-of-concept study is to determine the objective response rate in patients with unresectable, stage IIIB and IV non-small cell lung carcinoma treated with the combination cisplatin, docetaxel and bevacizumab. This response rate will be compared to historical data from the ECOG4599 and AVAiL trials. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Progression free survival, defined as the duration of time from first study treatment until progression or death from any cause as documented by the investigator. | 5 years | 
| Overall survival | Overall survival, defined as the duration of time from first study treatment until death from any cause. | 5 years | 
| Duration of response | Duration of response defined as timeframe from first response (CR or PR) until progression from best response. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AGMT, NSCLC, non-small cell lung cancer, bevacizumab, Avastin, Cisplatin, Docetaxel, Taxotere, Inoperable, stages IIIB and IV