Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Prostatic Neoplasms

In brief

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 facts

Study ID

NCT01683994

Run by

National Cancer Institute (NCI)

People needed

49

Starts

2012-09-07

Expected to finish

2019-01-16

Last updated by the study team

2019-11-08

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment
• The subject is unable to swallow tablets
• The subject has tumor invading (or there is concern for invasion of) major blood vessel
• The subject has active brain metastases or epidural disease Subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. Baseline brain scans are not required to confirm eligibility.
• The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel). Low dose aspirin (less than or equal to 81 milligrams per day), low-dose warfarin (less than or equal to1 milligrams per day), and prophylactic low molecular weight heparin (LMWH) are permitted.
• The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) greater than 500 milliseconds within 28 days before initiation of protocol therapy. Note: if initial QTcF is found to be greater than 500 milliseconds, two additional EKGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is less than or equal to 500 milliseconds, the subject meets eligibility in this regard.
• Patients with contraindication to steroid use
• Prior treatment with cabozantinib
• The patient has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 3 weeks, or nitrosoureas or mitomycin within 6 weeks before the first dose of study treatment.
• The subject has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment with the exception of patients receiving prior abiraterone or ketoconazole. For patients receiving prior abiraterone or ketoconazole, they must discontinue the medication within 5 half lives of the compound before the first dose of study treatment in order to participate in this study. Note: Subjects with prostate cancer currently receiving LHRH or GnRH agonists must be maintained on these agents.
• The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
• The subject has received radiation therapy:
• to the thoracic cavity or gastrointestinal tract within 3 months before the first dose of study treatment
• to bone or brain metastasis within 14 days before the first dose of study treatment
• to any other site(s) within 28 days before the first dose of study treatment
• The subject has received radionuclide treatment within 6 weeks prior to the first dose of the study treatment
• The subject has not recovered to baseline or CTCAE less than or equal to Grade 1 from toxicity due to all prior therapies, including surgery, except alopecia and other non-clinically significant AEs.
• The subject has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test results at screening greater than or equal 1.3 times the laboratory ULN within 7 days before the first dose of study treatment
• The subject has experienced any of the following:
• clinically-significant hematemesis or gastrointestinal bleeding within 6 months before the first dose of study treatment
• hemoptysis of greater than or equal to 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment
• any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
• The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
• Cardiovascular disorders including

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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