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
Inclusion Criteria:
1. 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.
2. Histologically confirmed diagnosis of advanced non small-cell lung carcinoma,
non-squamous cell
3. Patients age 18 years or more
4. Patients will be candidates to received a first line of chemotherapy of carboplatin,
paclitaxel and bevacizumab as the best therapeutic option.
5. Evidence of measurable disease per Response Evalutation Criteria in Solid tumors
(RECIST)
6. Patients must be avalaible for clinical follow-up
7. 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:
1. 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
2. history of haemoptysis (defined as at least half a teaspoon's emission of red blood)
in the 3 months prior to inclusion
3. evidence by CT of tumor cavitations, or tumours invading or abutting major blood
vessels
4. Known or suspected brain metastases non-treated.
5. Major surgery within 28 days of starting treatment.
6. Minor surgery within 24 hours before starting the treatment.
7. Non-controlled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg).
8. 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.
9. History or evidence of bleeding diathesis or hereditary coagulopathy.
10. Contraindication or suspected allergy to the products under investigation in the
study:: paclitaxel, carboplatine or bevacizumab.
11. 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.
12. Substance abuse of clinical, psychological or social conditions that can undermine
the validity of the informed consent or protocol compliance