Clinical Trial: Cabozantinib for Malignant Pheochromocytoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Pilot Study to Evaluate the Effects of Cabozantinib in Patients With Unresectable Metastatic Pheochromocytomas and Paragangliomas

Brief Summary: The goal of this clinical research study is to learn if cabozantinib can help to control advanced or metastatic pheochromocytoma or paraganglioma. The safety of this drug will also be studied.

Detailed Summary:

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take cabozantinib tablets by mouth 1 time each day. You should take your dose of study drug at about the same time each day, at least 1 hour before and 2 hours after eating a meal, with about a cup (8 ounces) of water. Do not crush the tablets.

If you forget to take your dose of cabozantinib and it has been less than 12 hours since the scheduled dose time, take your dose as soon as you remember. If it has been more than 12 hours, do not take the drug that day, and wait for your next scheduled dose.

Study Visits:

On Day -4 (4 days before you start taking the study drug):

  • You will have a physical exam.
  • Blood (about 2 teaspoons) and urine will be collected for routine tests.This routine blood draw may include a pregnancy test if you can become pregnant.
  • You will have an EKG.
  • You will answer 1 questionnaire about any symptoms you may be having. It should take about 10 minutes to complete. You will complete this questionnaire 1 time every week after you start the study drug . The study staff will tell you how to complete this questionnaire.
  • If you can become pregnant, urine may be collected for a pregnancy test.

On Day 1 of Weeks 3, 5, 7, 9, and then every 4 weeks after that until Week 24 (Weeks 13, 17, 21, and 24) and then every 8 weeks after that:

  • You will have a physical exam. Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: Overall Response Rate of Cabozantinib in Participants with Malignant Pheochromocytomas and Paragangliomas [ Time Frame: 8 weeks ]

    Primary endpoint is to estimate best overall response rate by RECIST 1.1 in participants with measurable disease determined by CT/MRI. Tumor response assessed at a frequency of 8 weeks. In participants with bone metastases, an FDG-PET scan obtained every 8 weeks.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: November 21, 2014
    Date Started: February 2015
    Date Completion: February 2019
    Last Updated: April 17, 2017
    Last Verified: April 2017