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.
Primary Outcome Measures:
- Palliative response rate [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of palliative response [ Designated as safety issue: No ]
- Biological response [ Designated as safety issue: No ]
- Tumor response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Quality of life as assessed by QLQ-PR25 [ Designated as safety issue: No ]
- Impact on autonomy in patients > 70 years of age [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: |
90 |
| Study Start Date: |
September 2006 |
| Estimated Primary Completion Date: |
September 2008 (Final data collection date for primary outcome measure) |
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.
Purpose
