Clinical Trial Details

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Study ID 12-1031
Investigator
Russell Szmulewitz,   University of Chicago Comprehensive Cancer Center
Title Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib on Bone Metastases in Patients With Castrate Resistant Prostate Cancer
Conditions Bone Metastases
Castrate-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Interventions Drug: cabozantinib
Other: laboratory biomarker analysis
Procedure: magnetic resonance imaging
Phase Phase 2
Purpose This study is being done to help researchers understand more about prostate cancer that has spread to the bones by using the newest magnetic resonance imaging (MRI) techniques and to better understand the effect of an experimental drug called XL184 (or cabozantinib) on bone disease. The other purposes of the study are to better understand the effect of XL184 on prostate cancer progression, bone pain, and on any cancer cells that patients may have circulating within the blood (called circulating tumor cells)
Eligibility Ages Eligible: N/A
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Histologically or cytologically confirmed prostate cancer with progressive disease
  • Evidence of castration resistance defined as disease progression despite a testosterone level < 50ng/dL (or surgical castration)
  • Evidence of metastatic disease to the bones within the lumbar spine, sacrum, or pelvic bones that is identifiable on screening pelvic MRI
  • If patient has had prior pelvis radiation therapy (RT), then bone metastases must be out of radiated port (e.g. lumbar or sacral spine)
  • Any prior therapy for castrate disease acceptable other than prior XL184 with a minimum washout of 28 days for any other anticancer therapy
  • Patients with castrate resistant disease post antiandrogen therapy/withdrawal must meet at least one of the following criteria: - Have not received docetaxel chemotherapy - Have received docetaxel chemotherapy but received less then 225mg/m2 cumulative dose - Have documented liver metastases - Have no pain or pain that does not require a long acting (SR) narcotic - Have received mitoxantrone chemotherapy in the past for CRPC
Exclusion Criteria:
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
  • Patients who are receiving any other investigational agents
  • Prior treatment with other vascular endothelial growth factor (VEGF) or c-MET targeted therapies
  • History of hematemesis or hemoptysis
  • The subject has uncontrolled or significant intercurrent illness
  • The patient requires concomitant treatment, in therapeutic doses, with anticoagulants
Study Location
University of Chicago
Chicago, Illinois, 60637-1470
Contact Elia Martinez, RN
773-702-3623
Information objtained from ClinicalTrials.gov, on 4/25/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599793


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