Treating Patients With Metastatic Prostate Cancer Not Responding to Hormone and Chemotherapy

Completed · Phase 1/Phase 2

Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone hydrochloride, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells

Key facts

Study ID

NCT00331344

Run by

National Cancer Institute (NCI)

People needed

100

Starts

2006-04-01

Expected to finish

2010-11-01

Last updated by the study team

2017-10-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate
• Progressive metastatic disease (i.e., positive bone scan or measurable disease) despite castrate levels of testosterone (either from orchiectomy or luteinizing hormone-releasing hormone [LHRH] agonist therapy)
• Progressive disease after discontinuing hormonal therapy
• Progressive disease is based on any of the following*:
• Transaxial imaging
• Rise in prostate-specific antigen (PSA)
• Radionuclide bone scan (must show new metastatic lesions)
• Nonmeasurable or measurable disease
• For measurable disease, progression is defined by RECIST criteria
• Positive bone scan and elevated PSA required for nonmeasurable disease
• PSA evidence of progressive prostate cancer during or after first-line chemotherapy consists of a PSA level ≥ 2 ng/mL that has risen on ≥ 2 successive occasions ≥ 1 week apart
• Received ≥ 3 prior courses of paclitaxel- or docetaxel-based therapy, with disease progression documented during therapy or after cessation of therapy
• No more than 1 prior chemotherapy regimen
• Re-treatment with the same taxane-based regimen allowed
• Changes in prior chemotherapy regimen (addition of other agents) for disease progression are considered 2 chemotherapy regimens, and are not allowed
• PSA ≥ 2 ng/mL
• Testosterone < 50 ng/dL
• Patients must continue primary androgen deprivation with LHRH analogue if they have not undergone orchiectomy
• No known active brain metastases
• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 40 mL/min
• ALT and AST < 2.5 times ULN
• Granulocyte count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³

Where it is running

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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