Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
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Lead
Groupe D'Etude des Tumeurs Uro-Genitales
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
* Metastatic progressive disease meeting the following criteria:
* Increase in measurable lesions \> 25%
* Increase in bone lesions \> 25%
* Biological progression rate of PSA \> 4 ng/mL
Received docetaxel as first-line chemotherapy
Received at least 1 prior regimen of hormone therapy
Pain \> 2 on Visual Analog Scale or continuing level 2 analgesics
No symptomatic or evolutionary CNS disease
PATIENT CHARACTERISTICS:
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Creatinine ≤ 1.5 times normal
Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
Transaminases ≤ 1.5 times normal
Bilirubin ≤ 1.5 times normal
No prior malignancy except basal cell skin cancer
No peripheral neuropathy or severe neuropathy ≥ grade 2
No other severe lung, hepatic, renal, or digestive disease that would be complicated by treatment
LVEF \> 50%
No history of peptic ulcer, unstable diabetes, or other contraindication to using steroids
No severe infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 8 weeks since prior metabolic radiotherapy
More than 4 weeks since prior external radiotherapy
At least 1 month since prior docetaxel-based chemotherapy
At least 1 month since prior antiandrogen therapy in the case of complete hormonal blockage
No participation in another clinical trial within the past 30 days
Clareo Health | Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
