Status:
COMPLETED
Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab
Lead Sponsor:
Spanish Lung Cancer Group
Conditions:
Nonsquamous Nonsmall Cell Neoplasm of Lung
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01814163
Start Date
February 1 2011
End Date
February 1 2013
Last Update
March 19 2013
Active Locations (20)
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1
H. Gen. Universitario Alicante
Alicante, Alicante, Spain
2
H. Clínico San Carlos
Madrid, Madrid, Spain
3
H. La Paz
Madrid, Madrid, Spain
4
H. Gen. Univ. Valencia
Valencia, Valencia, Spain