Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Prostate Cancer Clinical Trial

Official title: Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which drug is more effective in killing tumor cells.

PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to etoposide or vinorelbine works as second-line therapy in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the palliative response rate in patients with hormone-resistant prostate cancer treated with mitoxantrone hydrochloride vs etoposide vs vinorelbine ditartrate as second-line therapy.

Secondary

• Determine the duration of palliative response in patients treated with these regimens.

• Determine the biological response (PSA > 50%) in these patients.

• Determine the time to progression (biological and clinical) in these patients.

• Determine the overall survival of these patients.

• Determine the quality of life and the impact on autonomy of patients over 70 years of age.

• Determine the toxicity of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive mitoxantrone hydrochloride IV over 5 minutes once a week for 3 weeks.

• Arm II: Patients receive oral etoposide twice daily on days 1-14.

• Arm III: Patients receive oral vinorelbine ditartrate once daily on days 1 and 8 and oral prednisone once daily on days 1-21.

Treatment in all three arms repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00627354
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: September 2006