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A Randomized Study Comparing Aflibercept versus Placebo in Patients Treated with Second-Line Docetaxel after Failure of One Platinum-Based Therapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
[Protocol 08-075]
- Full Title :
- A MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND STUDY COMPARING AFIBERCEPT VERSUS PLACEBO IN PATIENTS TREATED WITH SECOND-LINE DOCETAXEL AFTER FAILURE OF ONE PLATINUM BASED THERAPY FOR LOCALLY ADVANCED OR METASTATIC NON-SMALL-CELL LUNG CANCER (NSCLC)
- Purpose :
Docetaxel is an anticancer drug approved for the treatment of lung cancer. In this study, researchers want to determine if adding an investigational drug called aflibercept to docetaxel treatment is more effective for improving the survival of patients with non-small cell lung cancer (NSCLC) than docetaxel alone. Patients with NSCLC that has persisted despite prior chemotherapy will be randomly assigned to receive docetaxel with aflibercept or a placebo.
Aflibercept (also called VEGF Trap) starves the tumor of an important growth factor (vascular endothelial growth factor, or VEGF) required for the growth of new blood vessels, which tumors need to grow and spread. Aflibercept is an antibody that binds to the VEGF blood vessel growth factor in the bloodstream. This binding results in fewer new blood vessels and reduced blood flow to the tumor.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have locally advanced or metastatic NSCLC that has persisted or progressed despite no more than one prior regimen of platinum-based chemotherapy.
- Patients may not have had prior treatment with docetaxel.
- At least 4 weeks must have passed since completion of prior chemotherapy and 42 days since any major surgery and entry into the study.
- Patients with brain metastases may not participate.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be at least 18 years of age.
For more information and to inquire about eligibility for this study, please contact Dr. Maria Catherine Pietanza at 212-639-6373.
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