Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01683994
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Assigned dose given daily during each 21 day cycle. Treatment may continue until disease progression or intolerable toxicity.
  • Docetaxel — DRUG
    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.
  • Prednisone — DRUG
    5 mg by mouth (PO) twice a day during each 21 day cycle until disease progression or intolerable toxicity.

Study Details

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.

Key Dates

Start date
Sep 7, 2012
Status verified
Oct 2019
Primary completion
Jul 1, 2018
Completion
Jan 16, 2019

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: combination of cabozantinib, docetaxel and prednisone
    combination of cabozantinib, docetaxel and prednisone
  • Active Comparator: PII/ Arm 1-docetaxel + prednisone only
    docetaxel + prednisone only
  • Active Comparator: PII/Arm 2 -docetaxel+ prednisone + cabozantinib
    docetaxel+ prednisone + cabozantinib

Primary Outcome Measure

Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone [ Time Frame: From start date of treatment until the date of first documented progression, date of death from any cause and up to 40 months, whichever occurred first. ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

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