CompletedNot Applicable

Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab

Spain200 participantsStarted 2011-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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:

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.

What they're measuring

Correlation between angiogenesis markers and progression free survival.

Timeframe: 1 year

Trial details

NCT IDNCT01814163

SponsorSpanish Lung Cancer Group

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-02

View on ClinicalTrials.gov More Nonsquamous Nonsmall Cell Neoplasm of Lung trials