Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab
ANGIOMET
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
1 other identifier
observational
200
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedMarch 19, 2013
March 1, 2013
2 years
July 18, 2012
March 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between angiogenesis markers and progression free survival.
1 year
Secondary Outcomes (5)
Overal survival
3 year
Survival at 12 and 24 months
12-24 months
Objective response
24 months
Duration of response
24 months
Treatment security
24 months
Study Arms (1)
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
Interventions
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
Eligibility Criteria
Patients with non-small cell lung cancer advanced unresectable, metastatic or recurrent, non-squamous and untreated with chemotherapy
You may qualify if:
- Histologically confirmed diagnosis of advanced non small-cell lung carcinoma, non-squamous cell
- Patients age 18 years or more
- Patients will be candidates to received a first line of chemotherapy of carboplatin, paclitaxel and bevacizumab as the best therapeutic option.
- Evidence of measurable disease per Response Evalutation Criteria in Solid tumors (RECIST)
- Patients must be avalaible for clinical follow-up
- 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.
You may not qualify if:
- 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
- evidence by CT of tumor cavitations, or tumours invading or abutting major blood vessels
- Known or suspected brain metastases non-treated.
- Major surgery within 28 days of starting treatment.
- Minor surgery within 24 hours before starting the treatment.
- Non-controlled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg).
- 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.
- History or evidence of bleeding diathesis or hereditary coagulopathy.
- Contraindication or suspected allergy to the products under investigation in the study:: paclitaxel, carboplatine or bevacizumab.
- 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.
- Substance abuse of clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bartomeu Massutí, MD
H. Gen. Univ.Alicante
- STUDY CHAIR
Carlos Camps, MD
H. Gen. Univ. Valencia
- STUDY CHAIR
Javier de Castro, MD
H. La Paz
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2012
First Posted
March 19, 2013
Study Start
February 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
March 19, 2013
Record last verified: 2013-03