Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cabazitaxel and Prednisone in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844582
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE July 26, 2016
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE December 20, 2017
Actual Primary Completion Date June 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
PSA response rate, defined as >= 50% decline in PSA from baseline maintained for at least 3 weeks and measured by the same laboratory, and without evidence of other disease progression documented at time of confirmatory values [ Time Frame: Up to 2 years ]
The response rate will be compared to a historical response rate of 20% using the exact binomial test for a single proportion. Confidence intervals for the response rate will be calculated using Wilson's method.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • Incidence of adverse events, serious adverse events, and discontinuations, described and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 28 days after discontinuation of study drug ]
    Laboratory values will be plotted over time.
  • Molecular markers or signature predictive of cabazitaxel benefit assessed from serum and tumor tissue specimens (to include status of AR pathway, androgen biosynthetic pathway genes, ABCB1, MRP1, and other mediators of taxane resistance, among others) [ Time Frame: Up to 18 weeks ]
    Continuous or ordered biomarkers will be compared between PSA responders and non-responders using the Wilcoxon rank sum test, and categorical biomarkers will be compared between PSA responders and non-responders using Fisher's Exact Test.
  • Overall survival (OS) defined as the time interval from the date of enrollment to the date of death due to any cause. [ Time Frame: From the date of enrollment to the date of death due to any cause, assessed up to 2 years ]
    Confidence intervals for the response rate will be calculated using Wilson's method. Medians will be estimated using the method of Kaplan and Meier, with confidence intervals estimated using Greenwood's method.
  • Progression-free survival (PFS) defined as the time interval between the date of enrollment and the date of the first documentation by the Prostate Cancer Working Group 2 (PCWG2) criteria. [ Time Frame: From date of enrollment to the date of the first documentation by PCWG2 criteria, assessed up to 2 years ]
    Confidence intervals for the response rate will be calculated using Wilson's method. Medians will be estimated using the method of Kaplan and Meier, with confidence intervals estimated using Greenwood's method.
  • Response Evaluation Criteria in Solid Tumors (RECIST) response defined as radiographic disease progression [ Time Frame: Up to 2 years ]
    Confidence intervals for the response rate will be calculated using Wilson's method. Medians will be estimated using the method of Kaplan and Meier, with confidence intervals estimated using Greenwood's method.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cabazitaxel and Prednisone in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Official Title  ICMJE A Selective Frontline Cabazitaxel Therapeutic Pathway for Castration-Resistant Prostate Cancer With Integrated Biomarkers
Brief Summary This phase II trial studies how well cabazitaxel and prednisone work in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed Description

PRIMARY OBJECTIVES:

I. To test whether men with a poor initial response to androgen deprivation therapy (ADT) have a better front line therapeutic response to cabazitaxel as compared to historical controls of frontline metastatic castrate resistant prostate cancer (CRPC) therapy with abiraterone or enzalutamide.

SECONDARY OBJECTIVES:

I. To determine the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 response rate, progression free survival (PFS) by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria, and overall survival (OS).

II. To evaluate safety and toxicity profile of cabazitaxel in patients with CRPC.

TERTIARY OBJECTIVES:

I. To collect serum and tumor tissue samples for molecular markers or signature predictive of cabazitaxel benefit (to include status of androgen receptor [AR] pathway, androgen biosynthetic pathway genes, adenosine triphosphate [ATP]-binding cassette sub-family B member 1 [ABCBI], multidrug resistance-associated protein 1 [MRP1], and other mediators of taxane resistance).

OUTLINE:

Patients receive cabazitaxel intravenously (IV) over 1 hour on day 1 and prednisone orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hormone-Resistant Prostate Cancer
  • Stage IV Prostate Adenocarcinoma
Intervention  ICMJE
  • Drug: Cabazitaxel
    Given IV
    Other Names:
    • Jevtana
    • RPR-116258A
    • Taxoid XRP6258
    • XRP-6258
  • Drug: Prednisone
    Given PO
    Other Names:
    • .delta.1-Cortisone
    • 1, 2-Dehydrocortisone
    • Adasone
    • Cortancyl
    • Dacortin
    • DeCortin
    • Decortisyl
    • Decorton
    • Delta 1-Cortisone
    • Delta-Dome
    • Deltacortene
    • Deltacortisone
    • Deltadehydrocortisone
    • Deltasone
    • Deltison
    • Deltra
    • Econosone
    • Lisacort
    • Meprosona-F
    • Metacortandracin
    • Meticorten
    • Ofisolona
    • Orasone
    • Panafcort
    • Panasol-S
    • Paracort
    • PRED
    • Predicor
    • Predicorten
    • Prednicen-M
    • Prednicort
    • Prednidib
    • Prednilonga
    • Predniment
    • Prednisonum
    • Prednitone
    • Promifen
    • Servisone
    • SK-Prednisone
Study Arms  ICMJE Experimental: Treatment (cabazitaxel, prednisone)
Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: Cabazitaxel
  • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2019)
2
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
45
Actual Study Completion Date  ICMJE June 4, 2019
Actual Primary Completion Date June 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma
  • Metastatic disease
  • Able and willing to provide informed consent and to comply with the study procedures
  • Castration resistant disease defined as evidence of radiological and/or prostate specific antigen (PSA) progression despite castrate levels of testosterone (serum testosterone < 50 ng/dL [1.7 nmol/L]); for PSA progression, there must be at least 2 sequential rises at a minimum of 1-week intervals; the first PSA value must be >= 4 (Prostate Cancer Working Group 2 [PCWG2] criteria)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • At least 21 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of =< 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration
  • At least 21 days have passed since receiving any investigational agent at the time of registration
  • At least 21 days have passed since major surgery
  • Neuropathy =< grade 1 at the time of registration
  • Has recovered from all therapy-related toxicity to =< grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy) at the time of registration
  • Poor prognosis disease as defined by any of the following:

    • PSA nadir >=4.0, or
    • Gleason score 8-10, or
    • Time from ADT initiation to CRPC of =< 16 months
  • Hemoglobin >= 90 g/L
  • Neutrophils >= 1.5 x 10^9 /L
  • Platelets >= 100 x 10^9/L
  • Aspartate aminotransferase (AST) < 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) < 1.5 x ULN
  • Bilirubin =< 1.0 x ULN (exceptions for Gilbert's syndrome)
  • Creatinine =< 1.5 x ULN

Exclusion Criteria:

  • Prior therapy with cabazitaxel or to other drugs formulated with polysorbate 80
  • Prior taxanes for CRPC
  • Prior enzalutamide, abiraterone or ketoconazole
  • Other condition, illness, psychiatric condition, or laboratory abnormality that may increase the risk associated with administration of cabazitaxel, study participation, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study
  • Histologic evidence of small cell/neuroendocrine prostate cancer
  • Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and up to 6 months after the last administered dose; the definition of "effective method of contraception" will be based on the investigator's judgment
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02844582
Other Study ID Numbers  ICMJE 868922
UCDCC#261 ( Registry Identifier: UC Davis IRB )
UCDCC#261 ( Other Identifier: University of California Davis Comprehensive Cancer Center )
NCI-2016-00961 ( Other Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: Christopher Evans University of California, Davis
PRS Account University of California, Davis
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP