Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
This is a observational study prospectively followed post-authorization.

Official Title
-----------------
Observational Studies to Explore the Relation Between Angiogenic Markers and the Treatment Response With Carboplatin, Paclitaxel and Bevacizumab in First Line of Advanced Non-small-cell Lung Cancer With Non- Squamous Histology

Conditions
-----------------
Nonsquamous Nonsmall Cell Neoplasm of Lung

Intervention / Treatment
-----------------
* Drug: paclitaxel, carboplatin and bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Absolute Neutrophil Count ANC > 1500/µl. Platelets > 100.000 /µl. Hemoglobine > 10 g/dl. Bilirrubin < 1.5 mg/dl. Aspartate aminotransfereasa (AST) and Alanine transaminase (ALT) ≤ 3 x LSN, except in case of hepatic metastases: upper 5 x LSN Creatinine clearance ≥ 45 ml/min. Exclusion Criteria: Previous treatment for advanced disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neadjuvant treatment history of haemoptysis (defined as at least half a teaspoon's emission of red blood) in the 3 months prior to inclusion evidence by CT of tumor cavitations, or tumours invading or abutting major blood vessels Known or suspected brain metastases non-treated. Major surgery within 28 days of starting treatment. Minor surgery within 24 hours before starting the treatment. Non-controlled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg). Patients with coronary disease or uncontrolled arrhytmia, uncontrolled cerebrovascular disease and other clinical conditions that, in judgment of the investigator, contraindicate the patient's participation in the study. History or evidence of bleeding diathesis or hereditary coagulopathy. Contraindication or suspected allergy to the products under investigation in the study:: paclitaxel, carboplatine or bevacizumab. Patients who are pregnant or breasfeeding. Women of childbearing potencial must have a negative pregnancy test performed within 7 days before the onset of treatment. Substance abuse of clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paclitaxel, carboplatin and bevacizumab<br>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 | Drug: paclitaxel, carboplatin and bevacizumab<br>* 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<br>* Other names: Taxol, carboplatin, avastin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between angiogenesis markers and progression free survival. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overal survival |  | 3 year | 
| Survival at 12 and 24 months |  | 12-24 months | 
| Objective response |  | 24 months | 
| Duration of response |  | 24 months | 
| Treatment security |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First line treatment, Non small cell lung cancer, non squamous