Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01845792
First received: April 29, 2013
Last updated: December 2, 2014
Last verified: December 2014
  Purpose

Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: Cabazitaxel with Abiraterone Acetate
Drug: Cabazitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel, Compared to Cabazitaxel Alone, in Patients With Metastatic Castrate Resistant Prostate Cancer.

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Efficacy [ Time Frame: Trial duration ] [ Designated as safety issue: No ]
    To assess the anti-cancer efficacy of abiraterone acetate and cabazitaxel, compared with cabazitaxel alone, in patients with CRPC, as determined by progression-free survival at 3 months.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: Trial duration ] [ Designated as safety issue: No ]
    To assess the anti-cancer activity of cabazitaxel vs. cabazitaxel with abiraterone acetate in patients with CRPC, after prior treatment with docetaxel and abiraterone acetate. Efficacy will be determined by PSA response, maximum PSA decline at anytime during study treatment, time to PSA and radiographic progression, radiographic objective response, median progression-free survival, and overall survival.

  • Safety and Tolerability [ Time Frame: Trial duration ] [ Designated as safety issue: Yes ]
    To assess ongoing safety and tolerability of the combination of abiraterone acetate and cabazitaxel.


Estimated Enrollment: 70
Study Start Date: July 2013
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabazitaxel with Abiraterone Acetate
Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.
Drug: Cabazitaxel with Abiraterone Acetate
Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.
Other Names:
  • Jevtana
  • Zytiga
Active Comparator: Cabazitaxel Alone
Cabazitaxel administered as a single intravenous dose every 3 weeks
Drug: Cabazitaxel
Cabazitaxel intravenously every 3 weeks
Other Name: Jevtana

Detailed Description:

Abiraterone acetate and cabazitaxel have been approved by the United States Food and Drug Administration (FDA) to treat prostate cancer that has spread to other parts of the body such as the lymph nodes or bone. These drugs are approved individually for use when the cancer has become resistant to other treatments, including chemotherapy with docetaxel. The combination of these two drugs has not been evaluated, so the research team will study the safety and effectiveness of the combination.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent has been obtained.
  • Adults over 18 years of age.
  • Histologically or cytologically proven adenocarcinoma of the prostate.
  • Stage IV disease as evidenced by soft tissue, visceral and/or bony metastasis must be RECIST evaluable on CT scan and/or bone scan
  • Progressive disease while receiving hormonal therapy or after surgical castration documented by at least one of the following: (1) Increase in measurable disease per RECIST 1.1, (2) Appearance of new lesions on bone scan consistent with progressive prostate cancer (>2 new lesions on bone scans if this is the only measure of PD), (3) rising PSA defined as 2 sequential increases above a previous lowest reference value. Each value must be obtained at least 1 week apart.
  • PSA at least 2 ng/mL
  • Received prior docetaxel chemotherapy
  • Received prior abiraterone acetate, but not within the 3 months prior to study drug dosing.
  • Testosterone level <50 ng/mL. Patients receiving LHRH agonists or antagonists must be continued to maintain castrate levels of testosterone while on study.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Adequate hematologic function (platelet >100, 000/uL; neutrophil count of >1500 cell/mm3; hemoglobin >9.0 g/dL)
  • Adequate renal function (Creatinine clearance > 50 mL/min)
  • Adequate potassium level > 3.5 mEq/dL
  • Adequate hepatic function (bilirubin < 1.5 X upper limit of normal (ULN), alanine aminotransferase (ALT) < 1.5 X ULN, aspartate aminotransferase (AST) < 1.5 X ULN. Have a serum albumin of ≥ 3.0 g/dL
  • Controlled blood pressure, defined as blood pressure ≤ 140/90 on average (3 separate readings taken at screening visit in a relaxed clinical environment and averaged)
  • Must be able to take oral medication without crushing, dissolving or chewing tablets
  • Willing to take abiraterone acetate on empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken.
  • Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
  • Written authorization for use and release of health and research study information has been obtained.
  • Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last dose of abiraterone acetate.

Exclusion Criteria:

  • Surgery or radiation therapy within 2 weeks. Cytotoxic anti-cancer therapy within 3 weeks. Non-cytotoxic anti-cancer therapy within 2 weeks, or 5 half-lives (whichever is shorter) of Study Day 1.
  • Prior radiotherapy to ≥ 40% of bone marrow.
  • Prior treatment with Radium 223.
  • Use of an investigational therapeutic agent within 30 days
  • Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
  • Prior treatment with cabazitaxel
  • Known chronic infection with human immunodeficiency virus (HIV)
  • Known active, or symptomatic, brain metastasis
  • Blood pressure >140/90 on average (3 separate readings taken at screening visit in a relaxed clinical environment and averaged)
  • History of autoimmune disorder requiring daily corticosteroid therapy of greater than prednisone 10mg daily, or its equivalent
  • Baseline peripheral edema > grade 3
  • Pre-existing diarrhea uncontrolled with supportive care; prior hemorrhagic diarrhea due to ulcerative colitis, inflammatory bowel disease or other cause; active, uncontrolled peptic ulcer disease even in the setting of proton-pump inhibitor or Histamine2-blocker use.
  • Pre-existing peripheral neuropathy grade > 2
  • Documented hypersensitivity (CTCAE grade > 2) to any drug containing polysorbate 80
  • Have known allergies or hypersensitivity to abiraterone acetate or prednisone or their excipients
  • Contraindications to steroid use
  • Need for medications that strongly induce or inhibit CYP3A4 or CYP2D6 activity. See section 7.2.3 for details
  • Serious infection requiring parenteral antibiotics within 14 days of enrollment
  • Poorly controlled diabetes (Hgb A1C >9)
  • Active or symptomatic viral hepatitis or chronic liver disease, including Child-Pugh Class B and C liver disease.
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III-IV heart disease or cardiac ejection fraction measurement of <50% at baseline.
  • Consumption of food or beverages containing grapefruit juice within 7 days of study drug dosing
  • Use of a first-generation anti-androgen such as bicalutamide within 6 weeks of study drug dosing, or flutamide within 4 weeks of study dosing.
  • Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845792

Contacts
Contact: Elaine Lam, MD 720-848-0170 elaine.lam@ucdenver.edu

Locations
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Elaine Lam, MD    720-848-0170    elaine.lam@ucdenver.edu   
Principal Investigator: Elaine Lam, MD         
Sponsors and Collaborators
University of Colorado, Denver
Janssen Services, LLC
Investigators
Principal Investigator: Elaine Lam, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01845792     History of Changes
Other Study ID Numbers: 13-1489.cc, NCI-2013-01356
Study First Received: April 29, 2013
Last Updated: December 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Metastatic Castrate Resistant Prostate Cancer

Additional relevant MeSH terms:
Prednisone
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015