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

May 31, 2018 updated by: University of Colorado, Denver

Phase II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel, Compared to Cabazitaxel Alone, in Patients With Metastatic Castrate Resistant Prostate Cancer.

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Response Evaluation Criteria in Solid Tumors (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 Leutinizing Hormone Releasing Hormone (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:

    1. platelet >100, 000/uL;
    2. neutrophil count of >1500 cell/mm3;
    3. hemoglobin >9.0 g/dL)
  • Adequate renal function (Creatinine clearance > 50 mL/min)
  • Adequate potassium level (> 3.5 mEq/dL)
  • Adequate hepatic function

    1. bilirubin < 1.5 X upper limit of normal (ULN),
    2. alanine aminotransferase (ALT) < 1.5 X ULN,
    3. aspartate aminotransferase (AST) < 1.5 X ULN.
    4. 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;

    (1) 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, or
  • Cytotoxic anti-cancer therapy within 3 weeks, or
  • 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 cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2D6 (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:

    1. myocardial infarction, or
    2. arterial thrombotic events in the past 6 months,
    3. severe or unstable angina, or
    4. New York Heart Association Class III-IV heart disease, or
    5. 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:

    1. bicalutamide within 6 weeks of study drug dosing, or
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cabazitaxel with Abiraterone Acetate
Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.
Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.
Other Names:
  • Zytiga
  • Jevtana
ACTIVE_COMPARATOR: Cabazitaxel Alone
Cabazitaxel administered as a single intravenous dose every 3 weeks
Cabazitaxel intravenously every 3 weeks
Other Names:
  • Jevtana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: 3 months
Progression-free survival at 3 months.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA Response
Time Frame: 2 years
Prostate specific antigen (PSA) decline by 50% or more from baseline.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2013

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (ESTIMATE)

May 3, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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