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Chemotherapy

Enzalutamide + Cabazitaxel for Prostate Cancer

Phase 1 & 2

Waitlist Available

Led By Julie N Graff

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of cabazitaxel given with enzalutamide for treating prostate cancer that has spread and no longer responds to hormone therapy.

Who is the study for?

This trial is for men with metastatic, hormone-resistant prostate cancer. Participants must have a good performance status (able to carry out daily activities), adequate blood counts and organ function, agree to use double barrier contraception, and be willing to provide a tumor sample if possible. Men who've had certain treatments or have specific health conditions are excluded.

What is being tested?

The study tests the combination of cabazitaxel (a chemotherapy drug) and enzalutamide (a hormone therapy) on patients with advanced prostate cancer that's spread and doesn't respond to hormonal treatment anymore. The phase I/II trial aims to find the best dose of cabazitaxel when used with enzalutamide.

What are the potential side effects?

Possible side effects include those common to chemotherapy like nausea, hair loss, low blood cell counts leading to increased infection risk or bleeding problems; fatigue; allergic reactions; liver issues; and potential interactions affecting other medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PSA Response 1, Defined as >= 90% PSA Decline From Baseline

Percentage of Participants With Dose Limiting ToxicitiesGgraded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (Phase I)

Secondary study objectives

Incidence of Adverse Events Graded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0

Overall Survival

PSA Response 2, Defined as >= 50% PSA Decline From Baseline

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cabazitaxel, enzalutamide)Experimental Treatment5 Interventions

Patients receive cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Cabazitaxel

2014

Completed Phase 3

~1290