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A Randomized, Open-Label Phase II/III Study of SU101 Plus Mitoxantrone/Prednisone Compared to Mitoxantrone/Prednisone Alone in Patients With Hormone-Refractory Prostate Cancer

Phase 2/Phase 3
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Randomized, Open-Label Phase II/III Study of SU101 Plus Mitoxantrone/Prednisone Compared to Mitoxantrone/Prednisone Alone in Patients With Hormone-Refractory Prostate Cancer

OBJECTIVES: I. Compare the percentage one year survival rate in hormone refractory prostate
cancer patients treated with leflunomide (SU101), mitoxantrone, and prednisone versus
mitoxantrone and prednisone alone. II. Compare the palliative pain response, time to
treatment failure, time to progression, median survival, investigator global response
assessment, objective response, time to palliative pain response, duration of palliation,
and effect on PSA between these two regimens. III. Assess the safety and tolerability of
mitoxantrone in combination with SU101 in these patients. IV. Assess the health related
quality of life of these patients on these regimens.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified by
performance status (70-80% vs 90-100%), baseline present pain intensity score (2.0 vs
greater than 2.0), and hemoglobin level (less than 12.0 g/dL vs at least 12.0 g/dL).
Patients enter one of two treatment arms: Arm I: Patients are premedicated with an IV 5-HT3
reuptake inhibitor (i.e., odansetron) then receive mitoxantrone IV on day 1. Twice daily
oral prednisone therapy begins on day 1 and continues throughout study treatment. Treatment
repeats every 21 days for 4 courses. Arm II: Patients are premedicated with an IV 5-HT3
reuptake inhibitor as in arm I. Patients receive mitoxantrone and prednisone therapy as in
arm I. Additionally, beginning on day 1 patients receive leflunomide (SU101) IV over 4-5
hours weekly for 12 weeks. The SU101 infusions shall precede mitoxantrone infusions.
Patients receive a maximum of one year therapy with SU101; mitoxantrone therapy may be
administered up to a maximum dose of 140/m2. Quality of life is assessed at baseline, day 8,
day 21, and then every 3 weeks thereafter until study completion. Patients are followed at
least every 2 months.

PROJECTED ACCRUAL: Up to 370 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven hormone refractory stage IV prostate cancer
Hormone refractory disease is defined as: Progressive measurable disease OR Progressive
disease by bone scan OR Increase in PSA by 50% over nadir level confirmed twice and
measured at least two weeks apart Prior treatment with primary androgen ablative therapy
with castrate levels of testosterone Minimum score of 2 on the McGill 6 point pain scale
secondary to metastatic bony pain with an analgesic score of at least 4 No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Greater than 16 weeks Hematopoietic: Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8.0 g/dL (without blood
transfusion(s) within 2 weeks prior to study) Hepatic: Bilirubin less than 1.5 times upper
limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than
2.0 mg/dL Cardiovascular: No cardiac failure No myocardial infarction within the past 6
months No uncontrolled hypertension LVEF greater than 50% Other: Fertile patients must use
effective barrier contraception during and for 3 months after study No known
hypersensitivity to polysorbate or polyethylene glycol No other malignancies within past 5
years, except basal cell skin cancer No other acute or chronic medical, psychiatric, or
lab abnormality that would prevent compliance No uncontrolled peptic ulcer No active
infection No contraindication to mitoxantrone therapy No contraindication to prednisone

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic response
modifiers At least 4 weeks since prior immunotherapy No concurrent immunotherapy
Chemotherapy: No prior SU101 or mitoxantrone No prior cytotoxic chemotherapy for prostate
cancer No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At
least 4 weeks since prior antiandrogen therapy and recovered Concurrent primary androgen
ablation therapy (orchidectomy, luteinizing hormone releasing hormone (LHRH) agonist (if
stable dose), estrogen, or cyproterone acetate) allowed No concurrent antiandrogen therapy
(except LHRH) No concurrent cholestyramine Radiotherapy: At least 4 weeks since prior
radiotherapy (8 weeks since strontium 89 and samarium 153) Prior palliative radiotherapy
to metastatic sites allowed No prior radiotherapy to greater than 50% of bone marrow No
concurrent radiotherapy except for palliation of bone pain Surgery: At least 2 weeks since
prior major surgery No concurrent surgery for prostate cancer Other: At least 4 weeks
since prior investigational therapy At least 4 weeks since prior antiangiogenesis therapy
At least 6 weeks since prior bicalutamide No other concurrent investigational therapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Mack H. Mabry, MD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 1999

Completion Date:

September 2007

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



St. Vincents Comprehensive Cancer Center New York, New York  10011
Florida Cancer Specialists Fort Myers, Florida  33901
Comprehensive Cancer Care Specialists of Boca Raton Boca Raton, Florida  33428