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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000765-33 | EudraCT Number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 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 |
| |
| Cisplatin | Drug | 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 | ||
| Docetaxel | Drug | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III | Salzburg | State of Salzburg | 5020 | Austria | ||
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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 |
| Univ.-Klinik für Innere Medizin V Innsbruck, Abteilung für Hämatologie und Onkologie |
| Innsbruck |
| Tyrol |
| 6020 |
| Austria |
| Landeskrankenhaus Feldkirch | Feldkirch | Vorarlberg | 6806 | Austria |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |