Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab

Completed

• Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung
• Interventions: Drug: paclitaxel, carboplatin and bevacizumab

• Registration Number: NCT01814163
• Lead Sponsor: Spanish Lung Cancer Group

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-07-18
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-18
• Last Update Submitted: 2013-03-18
• Study First Posted: 2013-03-19
• Last Update Posted: 2013-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paclitaxel, carboplatin and bevacizumab	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

Primary Outcome Measures

Name	Time	Method
Correlation between angiogenesis markers and progression free survival.	1 year

Secondary Outcome Measures

Name	Time	Method
Objective response	24 months
Duration of response	24 months
Treatment security	24 months
Survival at 12 and 24 months	12-24 months
Overal survival	3 year

Trial Locations

Locations (20)

H. Gen. Universitario Alicante; 🇪🇸 Alicante, Spain

Hospital General de L'Hospitalet; 🇪🇸 l'Hospitalet (Barcelona), Spain

Clínica Quirón; 🇪🇸 Madrid, Spain

Clinica Rotger; 🇪🇸 Palma de Mallorca, Spain

H. La Paz; 🇪🇸 Madrid, Spain

Hospital Provincial de Castellón; 🇪🇸 Castellón, Spain

Hospital General de Elche; 🇪🇸 Elche (Alicante), Spain

Hospital Insular Gran Canaria; 🇪🇸 Las Palmas, Spain

Hospital Ntra Sra Candelaria; 🇪🇸 Santa Cruz de Tenerife, Spain

Hospital Puerta de Hierro; 🇪🇸 Majadahonda (Madrid), Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Spain

Hospital Universitario Canarias; 🇪🇸 Santa Cruz de Tenerife, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Arnau de Vilanova; 🇪🇸 Valencia, Spain

H. Gen. Univ. Valencia; 🇪🇸 Valencia, Spain

Hospital Dr. Peset; 🇪🇸 Valencia, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Fundacion Jiménez Díaz; 🇪🇸 Madrid, Spain

H. Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Gregorio Marañon; 🇪🇸 Madrid, Spain