Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer
The goal of this clinical research study is learn if adding cabozantinib (also known as XL184) to hormonal therapy can help to control prostate cancer. The safety of this drug will also be studied.
Cabozantinib is designed to block certain proteins in your blood that cause cancer cells to grow. This may cause cancer cells to die.
Drug: Androgen Ablation Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Observational Study of XL-184 Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer|
- Progression Free Survival [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Castrate-resistant progression defined by any of the following: (a) radiographic progression (using RECIST 1.1 for visceral disease and PCWG2 for Bone Scans), (b) receipt of additional anti-cancer therapy, or (c) clinical progression warranting discontinuation from the study as judged by the treating physician.
|Study Start Date:||January 2014|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Cabozantinib + Androgen Ablation Therapy
Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive.
Starting dose of 60 mg by mouth every day of a 21 day cycle.
Other Name: XL 184Drug: Androgen Ablation Therapy
Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 1 capsule of cabozantinib by mouth 1 time every day while you are on study. You should not eat or drink anything other than water for 2 hours before and 1 hour after taking the study drug. You should take the capsule with at least 1 cup (8 ounces) of water. You will also be given separate directions about how to take the study drug.
You will also receive hormone therapy. The hormone drug you receive will be standard of care hormone therapy. The study doctor will decide what hormone therapy you will receive and will explain when and how you should take the hormone therapy, as well as its risks.
You will be given a drug diary where you will record when you take cabozantinib. You should return this diary to the study staff when you come into the clinic.
At every visit, you will be asked about any side effects you may have had and any other drugs you may be taking.
Every 3 weeks for the first 12 weeks of the study, and then every 6 weeks after that:
- You will have a physical exam.
- Blood (about 3-4 teaspoons) will be drawn for routine tests. Every 6 weeks, this blood will also be used to check your thyroid function and measure your PSA.
- Urine will be collected for routine tests (every 6 weeks).
Every 12 weeks, you will have a bone scan and CT scans of the chest, abdomen, and pelvis to check the status of the disease.
Length of Study:
You may continue receiving the study drug for as long as the study doctor thinks it is in your best interest. You will be taken off study early if the disease gets worse, if you have intolerable side effects, or if your study doctor thinks it is in your best interest to stop.
You will be contacted every 6 months after you stop taking the study drug to check on how you are feeling and the status of the disease. This will consist of a phone call, e-mail, or medical record review. If you are called, each call should last about 5 minutes.
This is an investigational study. Cabozantinib is FDA approved to treat patients with certain types of thyroid cancer. Its use in this study is investigational.
Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630590
|Contact: Paul Corn, MD, PHD||713-792-2830|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Paul Corn, MD, PHD||M.D. Anderson Cancer Center|