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This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line therapy in patients with non-squamous advanced non-small cell lung cancer.
This is a observational study prospectively followed post-authorization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel, carboplatin and bevacizumab | Paclitaxel 200 mg/m2, carboplatin area under curve (AUC) 6 mg/ml/min plus bevacizumab 15 mg/kg on day 1, every 21 days. Total number of cycles: 6. After 6 cycles bevacizumab on monotherapy until progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel, carboplatin and bevacizumab | Drug | Paclitaxel 200 mg/m2, carboplatin area under curve (AUC) 6 mg/ml/min plus bevacizumab 15 mg/kg on day 1, every 21 days. Total number of cycles: 6. After 6 cycles bevacizumab on monotherapy until progression |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between angiogenesis markers and progression free survival. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overal survival | 3 year | |
| Survival at 12 and 24 months | 12-24 months | |
| Objective response |
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Inclusion Criteria:
Patients should sign inform consent before inclusion in the study that specifies that the clinical treatment entails consent for the analysis of biological samples of tumor and blood.
Histologically confirmed diagnosis of advanced non small-cell lung carcinoma, non-squamous cell
Patients age 18 years or more
Patients will be candidates to received a first line of chemotherapy of carboplatin, paclitaxel and bevacizumab as the best therapeutic option.
Evidence of measurable disease per Response Evalutation Criteria in Solid tumors (RECIST)
Patients must be avalaible for clinical follow-up
Patients with the following hematologic/biochemical values:
Exclusion Criteria:
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Patients with non-small cell lung cancer advanced unresectable, metastatic or recurrent, non-squamous and untreated with chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Bartomeu Massutí, MD | H. Gen. Univ.Alicante | Study Chair |
| Carlos Camps, MD | H. Gen. Univ. Valencia | Study Chair |
| Javier de Castro, MD | H. La Paz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Gen. Universitario Alicante | Alicante | Alicante | Spain | |||
| H. Clínico San Carlos |
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| Label | URL |
|---|---|
| Spanish Lung Cancer Group website | View source |
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|
| 24 months |
| Duration of response | 24 months |
| Treatment security | 24 months |
| Madrid |
| Madrid |
| Spain |
| H. La Paz | Madrid | Madrid | Spain |
| H. Gen. Univ. Valencia | Valencia | Valencia | Spain |
| Hospital Provincial de Castellón | Castellon | Spain |
| Hospital General de Elche | Elche (Alicante) | Spain |
| Hospital General de L'Hospitalet | l'Hospitalet (Barcelona) | Spain |
| Hospital Insular Gran Canaria | Las Palmas | Spain |
| Clínica Quirón | Madrid | Spain |
| Fundacion Jiménez Díaz | Madrid | Spain |
| Hospital Gregorio Marañon | Madrid | Spain |
| Hospital Puerta de Hierro | Majadahonda (Madrid) | Spain |
| Clinica Rotger | Palma de Mallorca | Spain |
| Hospital Son Espases | Palma de Mallorca | Spain |
| Hospital Ntra Sra Candelaria | Santa Cruz de Tenerife | Spain |
| Hospital Universitario Canarias | Santa Cruz de Tenerife | Spain |
| Hospital Arnau de Vilanova | Valencia | Spain |
| Hospital Dr. Peset | Valencia | Spain |
| Hospital La Fe | Valencia | Spain |
| Hospital Miguel Servet | Zaragoza | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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