NCT02844582

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

A Selective Frontline Cabazitaxel Therapeutic Pathway for Castration-Resistant Prostate Cancer With Integrated Biomarkers

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hormone-Resistant Prostate Cancer
• Stage IV Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Cabazitaxel	Given IV
DRUG	Prednisone	Given PO

Timeline

• Start date: 2017-12-20
• Primary completion: 2019-06-04
• Completion: 2019-06-04
• First posted: 2016-07-26
• Last updated: 2021-01-25
• Results posted: 2021-01-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study