Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab

NCT ID: NCT01814163

Last Updated: 2013-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-02-28

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.

Conditions

Nonsquamous Nonsmall Cell Neoplasm of Lung

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

paclitaxel, carboplatin and bevacizumab

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Taxol, carboplatin, avastin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Lung Cancer Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bartomeu Massutí, MD

Role: STUDY_CHAIR

H. Gen. Univ.Alicante

Carlos Camps, MD

Role: STUDY_CHAIR

H. Gen. Univ. Valencia

Javier de Castro, MD

Role: STUDY_CHAIR

H. La Paz

Locations

H. Gen. Universitario Alicante

Alicante, Alicante, Spain

H. Clínico San Carlos

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

Countries

Spain

Related Links

http://www.gecp.org/

Spanish Lung Cancer Group website

Other Identifiers

GECP 09-02

Identifier Type: -

Identifier Source: org_study_id