5305W-12: Exelixis prostate

CRC 12061: A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

Type of Study
Cancer (Oncology) - Prostate
Location
Swedish Cancer Institute
Short Description

Purpose: Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases.

This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

Status
Open to Enrollment
Principal Investigator
Howard (Jack) West, M.D.
Eligibility Notes
  • Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dL)
  • Evidence of bone metastasis related to prostate cancer on bone scans
  • Documented pain from bone metastases that requires opioid narcotic intervention
  • Adopted a narcotic regimen that consists of one sustained release opioid agent taken daily for chronic pain and one immediate release opioid agent for breakthrough pain
  • Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or MDV3100 treatment and has evidence of investigator assessed prostate cancer progression on each agent independently
  • Maintenance of LHRH agonist or antagonist unless treated with orchiectomy
  • No prior treatment with cabozantinib or mitoxantrone
  • No prior treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks
  • No prior radiation therapy in the last 4 weeks (includes radiation targeting bone metastases), radionuclide treatment in the last 6 weeks, or radiation therapy to the thoracic cavity (unless radiation targets bone metastases) in the past 3 months
  • No prior treatment with serotonergic psychiatric medication(s) in the last 2 weeks (5 weeks for fluoxetine)
  • Must be able to swallow capsules or tablets or tolerate infusions
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org