Spots Global Cancer Trial Database for Mitoxantrone and G-CSF in Treating Patients With Metastatic Prostate Cancer

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Trial Identification

Brief Title: Mitoxantrone and G-CSF in Treating Patients With Metastatic Prostate Cancer

Official Title: A Phase I/II Trial Using Weekly Mitoxantrone Chemotherapy and G-CSF for the Treatment of Metastatic Hormone Refractory Prostate Cancer

Study ID: NCT00003183

Conditions

Prostate Cancer

Interventions

filgrastim

mitoxantrone hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with G-CSF may make tumor cells more sensitive to the chemotherapy drug and may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of mitoxantrone plus G-CSF in treating patients with metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description: OBJECTIVES: I. Study the effectiveness of mitoxantrone in patients with metastatic, hormone refractory prostate cancer. II. Assess the side effects of mitoxantrone in this patient population. III. Determine whether filgrastim (granulocyte colony-stimulating factor; G-CSF) treatment can overcome chronic bone marrow suppression and facilitate a dose intensive mitoxantrone chemotherapy regimen in this patient population. OUTLINE: This is a dose escalation study. Patients receive a 30 minute intravenous infusion of mitoxantrone once a week on day 1. On days 2-6 of each week, patients receive subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF). Treatment continues for patients who respond to therapy and exhibit no disease progression. Dose escalation proceeds until the maximum tolerated dose (MTD) of mitoxantrone with G-CSF support is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. After the MTD is determined, an additional 20-40 patients are enrolled at this dose level to examine their response to this therapy. PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for the phase I portion of this protocol. An additional 20-40 patients may be accrued for the phase II portion of this study.