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

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.

Study Overview

• Status: Completed
• Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung
• Intervention / Treatment: Drug: paclitaxel, carboplatin and bevacizumab

Detailed Description

This is a observational study prospectively followed post-authorization.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • H. Gen. Universitario Alicante
  • Castellón, Spain
    • Hospital Provincial de Castellón
  • Elche (Alicante), Spain
    • Hospital General de Elche
  • Las Palmas, Spain
    • Hospital Insular Gran Canaria
  • Madrid, Spain
    • H. Clínico San Carlos
  • Madrid, Spain
    • Hospital Gregorio Marañón
  • Madrid, Spain
    • Fundacion Jimenez Diaz
  • Madrid, Spain
    • Clinica Quiron
  • Madrid, Spain
    • H. La Paz
  • Majadahonda (Madrid), Spain
    • Hospital Puerta de Hierro
  • Palma de Mallorca, Spain
    • Clinica Rotger
  • Palma de Mallorca, Spain
    • Hospital Son Espases
  • Santa Cruz de Tenerife, Spain
    • Hospital Ntra Sra Candelaria
  • Santa Cruz de Tenerife, Spain
    • Hospital Universitario Canarias
  • Valencia, Spain
    • H. Gen. Univ. Valencia
  • Valencia, Spain
    • Hospital Arnau de Vilanova
  • Valencia, Spain
    • Hospital La Fe
  • Valencia, Spain
    • Hospital Dr. Peset
  • Zaragoza, Spain
    • Hospital Miguel Servet
  • l'Hospitalet (Barcelona), Spain
    • Hospital General de l'Hospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-small cell lung cancer advanced unresectable, metastatic or recurrent, non-squamous and untreated with chemotherapy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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; Other Names: Taxol, carboplatin, avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between angiogenesis markers and progression free survival.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Spanish Lung Cancer Group
• Investigators: 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

Publications and helpful links

Helpful Links

• Spanish Lung Cancer Group website

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: March 18, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Estimate): March 19, 2013
• Last Update Submitted That Met QC Criteria: March 18, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: First line treatment; Non small cell lung cancer, non squamous
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Paclitaxel; Bevacizumab
• Other Study ID Numbers: GECP 09-02