Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer
- 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.
- 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
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Palliative response rate
Florence Joly, MD, PhD
Centre Francois Baclesse
United States: Federal Government