At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I and Randomized Phase II Multicenter Study of Cabozantinib (XL184) Plus Docetaxel and Prednisone in Metastatic Castrate Resistant Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Cabozantinib, Docetaxel, and 1 other intervention for Prostatic Neoplasms. Completed, enrolled 49 participants across 1 site.
Detailed Summary
Background: \- Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate tumors respond to it. Docetaxel and prednisone are standard treatments for advanced prostate cancer. Researchers want to see if adding cabozantinib to these two drugs can be a safe and effective treatment for this type of cancer. Objectives: \- To test the safety and effectiveness of cabozantinib with standard treatments for advanced prostate cancer. Eligibility: \- Individuals at least 18 years of age who have advanced prostate cancer that has not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will also be performed. * Participants will receive the cancer drugs over 21-day cycles of treatment. They will take docetaxel and cabozantinib on day 1 of each cycle. Each docetaxel infusion will take about 1 hour. They will also take prednisone by mouth twice each day. * Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take the study drugs for as long as their cancer does not worsen and side effects are not too severe.
Study Details
Timeline
Interventions
Assigned dose given daily during each 21 day cycle. Treatment may continue until disease progression or intolerable toxicity.
75mg/m\^2 intravenous (IV) over approximately 60 minutes on cycle 1 day 1 and repeated every 21 days until disease progression or intolerable toxicity.
5 mg by mouth (PO) twice a day during each 21 day cycle until disease progression or intolerable toxicity.