Services / Prostate Cancer - Aflibercept
Trial Information
Prostate Cancer: Clinical trial of Aflibercept in combination with chemotherapy for men with metastatic disease.
- Principal Investigator: Matthew Rettig, M.D.
- Co-Investigators: Jean deKernion, M.D., Arie Belldegrun, M.D., Allan Pantuck, M.D., Robert Reiter, M.D., Fairooz Kabbinavar, M.D.
This trial is currently accepting new patient applications
Objective:
A study comparing treatment of metastatic disease with a combination of Aflibercept and chemotherapy (Docetaxel/prednisone) versus chemotherapy alone.
The purpose of this study is to test the efficacy of the research study drug, Aflibercept, and to see if Aflibercept with Docetaxel [TAXOTERE®] / prednisone (oral cortisone) is better than Docetaxel/prednisone alone.
Part of the reason tumors are able to grow and spread in the body is because of a substance called Vascular Endothelial Growth Factor (VEGF), which is made by many types of cancer cells. VEGF causes the growth of new blood vessels into tumors, giving them nourishment and maintaining their ability to grow and spread. Research studies have shown that Aflibercept blocks the ability of VEGF to cause formation and growth of new blood vessels in tumors. This has been shown in animal and human studies.
Trial Design
Randomized, Blinded, Phase 3 Study
If you are eligible to take part in this study, you will be randomly placed into one of the study groups below. You will have a 1 in 2 chance (50%) of getting aflibercept.
This study is “blinded.” This means that neither you nor your study doctor will know in which group you are placed. However, if needed for safety or health reasons, your study doctor can find out your study group at any time.
Groups
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Intervention
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1: Experimental
Aflibercept
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Docetaxel prednisone
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Drug: Aflibercept
IV infusion at a dose of 6mg/kg over 1 hour period followed by IV infusion of Docetaxel (1 hour period) administered every 3 weeks.
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2:Placebo Control
Placebo
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Docetaxel prednisone
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Drug: Placebo
IV infusion (1hour) followed by IV infusion of Docetaxel (1 hour) administered every 3 weeks.
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Patient Eligibility
Inclusion Criteria:
- Histologically- or cytologically-confirmed prostate adenocarcinoma
- Metastatic disease
- Progressive disease while receiving hormonal therapy or after surgical castration
Exclusion Criteria:
- Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed > 3 years ago
- Prior treatment with VEGF inhibitors or VEGF receptor inhibitors
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
For more information
For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call recruitment coordinator Diana Sarkisyan at (310) 206-7793 (dsarkisyan@mednet.ucla.edu) or Nazy Zomorodian, Director for the Clinical Trials Office at (310) 794-7704.
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