Skip to main content
OpenTrials
Completed

NCT Number: NCT01814163

Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

H. Gen. Universitario Alicante, Alicante, Spain

Loading trial locations.

About this study

This is a observational study prospectively followed post-authorization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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
  • history of haemoptysis (defined as at least half a teaspoon's emission of red blood) in the 3 months prior to inclusion
  • 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

Treatment and study plan

paclitaxel, carboplatin and bevacizumab

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

Other names: Taxol, carboplatin, avastin

Primary outcomes

  1. Correlation between angiogenesis markers and progression free survival.

    Time frame: 1 year

Secondary outcomes

  1. Overal survival

    Time frame: 3 year

  2. Survival at 12 and 24 months

    Time frame: 12-24 months

  3. Objective response

    Time frame: 24 months

  4. Duration of response

    Time frame: 24 months

  5. Treatment security

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Spanish Lung Cancer Group

Other

Registry information

Official study 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

Acronym: ANGIOMET

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2013
Registry last updated
Mar 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.