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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: etoposide
* Drug: mitoxantrone hydrochloride
* Drug: prednisone
* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: etoposide|nan|
|Drug: mitoxantrone hydrochloride|nan|
|Drug: prednisone|nan|
|Drug: vinorelbine tartrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palliative response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of palliative response |  |  | 
| Biological response |  |  | 
| Tumor response as assessed by RECIST criteria |  |  | 
| Time to progression |  |  | 
| Overall survival |  |  | 
| Quality of life as assessed by QLQ-PR25 |  |  | 
| Impact on autonomy in patients > 70 years of age |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate