Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Palliative response rate
Safety Issue:
No
Principal Investigator
Florence Joly, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Francois Baclesse
Authority:
United States: Federal Government
Study ID:
CDR0000574184
NCT ID:
NCT00627354
Start Date:
September 2006
Completion Date:
Related Keywords:
- Prostate Cancer
- stage IV prostate cancer
- recurrent prostate cancer
- adenocarcinoma of the prostate
- Prostatic Neoplasms
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