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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

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.

Condition or disease Intervention/treatment Phase
Hormone-Resistant Prostate Cancer Stage IV Prostate Adenocarcinoma Drug: Cabazitaxel Drug: Prednisone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Selective Frontline Cabazitaxel Therapeutic Pathway for Castration-Resistant Prostate Cancer With Integrated Biomarkers
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : June 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844582


Locations
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United States, California
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Sanofi
Investigators
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Principal Investigator: Christopher Evans University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02844582    
Other Study ID Numbers: 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) )
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Prednisone
Cortisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents