Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab

Nonsquamous Nonsmall Cell Neoplasm of Lung Clinical Trial

— ANGIOMET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814163
• Other study ID #: GECP 09-02
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: March 18, 2013
• Start date: February 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Spanish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Description:

This is a observational study prospectively followed post-authorization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsquamous Nonsmall Cell Neoplasm of Lung

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Spain	H. Gen. Universitario Alicante	Alicante
Spain	Hospital Provincial de Castellón	Castellón
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	H. Clínico San Carlos	Madrid
Spain	H. La Paz	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	H. Gen. Univ. Valencia	Valencia
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Dr. Peset	Valencia
Spain	Hospital La Fe	Valencia
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Lung Cancer Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between angiogenesis markers and progression free survival.		1 year	No
Secondary	Overal survival		3 year	No
Secondary	Survival at 12 and 24 months		12-24 months	No
Secondary	Objective response		24 months	No
Secondary	Duration of response		24 months	No
Secondary	Treatment security		24 months	Yes

External Links

•   Spanish Lung Cancer Group website