Ixabepilone Compared With Mitoxantrone and Prednisone in Treating Patients With Refractory Metastatic Prostate Cancer

Completed · Phase 2

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

In brief

This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Ixabepilone may reduce resistance to the drugs and allow the tumor cells to be killed. It is not yet known which chemotherapy regimen is more effective in treating metastatic prostate cancer

Key facts

Study ID

NCT00058084

Run by

National Cancer Institute (NCI)

People needed

80

Starts

2003-03-01

Last updated by the study team

2017-02-23

Who can join

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

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate
• Metastatic disease (positive bone scan or measurable disease)
• Progressive hormone-refractory disease
• Based on 1 of the following:
• Transaxial imaging
• Rise in prostate-specific antigen (PSA)
• Radionuclide bone scan
• Must have undergone primary hormonal treatment (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without an antiandrogen) and demonstrated disease progression after antiandrogen discontinuation as defined below:
• Two consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression
• For patients receiving flutamide, at least 1 PSA value must be obtained at least 4 weeks after flutamide discontinuation
• For patients receiving bicalutamide or nilutamide, at least 1 PSA value must be obtained at least 6 weeks after antiandrogen discontinuation
• Ineligible if sole manifestation of progression is an increase in disease-related symptoms
• Meets 1 of the following criteria:
• Measurable disease and an elevated PSA
• Nonmeasurable disease and an elevated PSA, as follows:
• Positive bone scan
• PSA level at least 5 ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart
• New metastatic lesions by radionuclide bone scan
• Must have received at least 2 courses of paclitaxel- or docetaxel-based therapy, with disease progression documented during therapy or no more than 60 days after cessation of therapy*
• Testosterone < 50 ng/dL
• No known active brain metastases
• Performance status - ECOG 0-2
• At least 12 weeks
• Granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3

Where it is running

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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