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

NCT02844582 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 868922UCDCC#261NCI-2016-00961
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone-Resistant Prostate Cancer; Stage IV Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (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

  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.

  Up to 18 months.

Secondary Outcomes (4)

• 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

  Up to 28 days after discontinuation of study drug

• Overall Survival (OS) Defined as the Time Interval From the Date of Enrollment to the Date of Death Due to Any Cause.

  Up to 18 months.

• 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.

  Approximately 5 months.

• Response Evaluation Criteria in Solid Tumors (RECIST) Response Defined as Radiographic Disease Progression

  Approximately 5 months.

Study Arms (1)

Treatment (cabazitaxel, prednisone)

EXPERIMENTAL

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; Drug: Prednisone

Interventions

Cabazitaxel DRUG

Given IV

Also known as: Jevtana, RPR-116258A, Taxoid XRP6258, XRP-6258

Treatment (cabazitaxel, prednisone)

Prednisone DRUG

Given PO

Also known as: .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

Treatment (cabazitaxel, prednisone)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Sanofi: collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

cabazitaxel; XRP6258; Prednisone; deltacortene; prednylidene

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Analyst
• Organization: University of California, Davis

nlogihara@ucdavis.edu

916-734-8053

Study Officials

• Christopher Evans

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 26, 2016
• Study Start: December 20, 2017
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: January 25, 2021
• Results First Posted: January 25, 2021

Record last verified: 2021-01

Locations

US (1)