Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab (ANGIOMET)

Spanish Lung Cancer Group

Status: Completed

Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung

Treatments: Drug: paclitaxel, carboplatin and bevacizumab

Study type: Observational

Funder types: Other

Identifiers

NCT01814163

GECP 09-02

Details and patient eligibility

About

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.

Full description

This is a observational study prospectively followed post-authorization.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Paclitaxel, carboplatin and bevacizumab

Description:

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

Treatment:

Drug: paclitaxel, carboplatin and bevacizumab