Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Hormones

Prolactin Release-Inhibiting Factors

Hormone Antagonists

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.

Cabozantinib

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.

Androgen Ablation Therapy

Paul Corn, MD, PHD

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.

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.

Study Visits:

At every visit, you will be asked about any side effects you may have had and any other drugs you may be taking.

If you are receiving Coumadin, every week for the first 3 weeks, you will have blood drawn (about 1 teaspoon) to test your blood clotting function.

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 3 weeks for the first 12 weeks of the study, and then every 12 weeks after that, blood (about 1 teaspoon) will be drawn to check your thyroid and pancreatic function. The frequency of the testing may change if the study doctor thinks it is needed.

Every 6 weeks, you will have the following tests performed:

* Blood (about 2-3 teaspoons) will be drawn to measure your PSA levels and for biomarker testing.
* Urine will be collected for routine tests.
* You may have these test performed near your home if the study doctor thinks you are tolerating the treatment.

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.

Long-Term Follow-Up:

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.

Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer

An Observational Study of XL-184 Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer

Progression defined by any of the following: (a) radiographic progression (using RECIST 1.1 for visceral disease and PCWG2 for Bone Scans), (b) receive additional anti-cancer therapy, or (c) clinical progression resulting in stopping the treatment.

Number of instances of Serious Adverse Events and Other (Not Including Serious) Adverse Events. Adverse events were monitored for 30 days beyond the last day of treatment. These adverse events are documented. The adverse events are reported as Serious Adverse Events and Adverse Events. Serious Adverse Events are defined as adverse events in which the participant dies, is hospitalized, is disabled, or is exposed to the medicine while pregnant resulting in and birth defect. Adverse events evaluated for all treated participants using the NCI CTCAE version 4.3.

Exelixis

High Impact Clinical Research Support Program

M.D. Anderson Cancer Center

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.

Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle.

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.

Cabozantinib + Androgen Ablation Therapy

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Grade 0

Grade 1

Grade 2

ECOG measure a participant's daily living abilities. All participants in this trial are grade 0, grade 1, or grade 2.

Grade 0: Fully active on all pre-disease performance without restriction Grade 1: light housework and office work. Restricted in physically strenuous activity Grade 2: Ambulatory and capable of self-care. Not able to carry out work that is light or sedentary.

Eastern Cooperative Oncology Group (ECOG) Performance Status

No Prior Treatment

Yes Prior Treatment

Prior Treatment of Primary Tumor

Gleason 6-7

Gleason 7 + 5

Gleason 8-10

Unknown Gleason Score

Gleason score grades prostate cancer based on the severity of the cancer The scores range from 2 -10. The higher the score the more severe the cancer. Gleason Score of 6 is the lowest cancer grade. In this trial, participants who have a traditional Gleason 7 score with an additional area in the prostate that meets Gleason 5 score were counted separately and labeled Gleason 7 + 5.

Gleason Score

PSA is produced by normal and cancerous prostate tissue. PSA levels are often elevated in men with prostate cancer.

Prostate Specific Antigen (PSA) Levels

Only 59 of the participants had bone specific Alkaline Phosphatase level as baseline

Bone Specific Alkaline Phosphatase Level

Bone Metastases

Bone Only

Bone metastases measures help define the extent on the prostate cancer in the participants. The first measure, Bone Metastases counted the number of participants with bone metastasis. The second measure, Bone Only, counted the number of patients who only had prostate cancer present in the bone.

Visceral Metastases measurement determined how many participants at baseline had prostate tumors in any of the organs of the body. This measurement did not include bone or lymph nodes.

Visceral Metastases

None

Lymph Nodes

Liver

Lung

Soft-Tissue Metastases

High

The volume of metastases was categorized as high or low. A high volume was defined as a participant who had 3 or more bone tumors and/or visceral tumors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer	NCT01630590	Prostate Cancer	Cabozantinib Androgen Ablati...	-	M.D. Anderson Cancer Center
Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer	NCT01630590	Prostate Cancer	Cabozantinib Androgen Ablati...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for xl 184

Every month we try and update this database with for xl 184 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for xl 184

Every month we try and update this database with for xl 184 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for xl 184 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.