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Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer

NCT01683994 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-11-08

Study results available
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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.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Cabozantinib

Assigned dose given daily during each 21 day cycle. Treatment may continue until disease progression or intolerable toxicity.

DRUG

Docetaxel

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.

DRUG

Prednisone

5 mg by mouth (PO) twice a day during each 21 day cycle until disease progression or intolerable toxicity.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • William L Dahut, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-07
Primary Completion
2018-07-01
Completion
2019-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01683994 on ClinicalTrials.gov