A Phase II Trial of Adjuvant Mitoxantrone (NSC #301739) for High Risk Patients Following Radical Prostatectomy
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase II Trial of Adjuvant Mitoxantrone (NSC #301739) for High Risk Patients Following Radical Prostatectomy
OBJECTIVES: I. Assess the feasibility of enrolling patients with adenocarcinoma of the
prostate at high risk for recurrence following radical prostatectomy in an adjuvant
mitoxantrone trial. II. Determine if this adjuvant therapy results in a delay in time to
failure or a decrease in the number of treatment failures compared to historical controls in
this patient population.
OUTLINE: Patients receive mitoxantrone IV over 10-30 minutes every 21 days. Treatment
continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease
progression. Patients are followed every 3 months for the first 3 years, and then every 6
months for the next 3 years or until disease progression.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study over 18 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Adenocarcinoma of the prostate treated by radical prostatectomy
within the past 3 months Considered to be at high risk for recurrence as defined by at
least 1 of the following characteristics on the radical prostatectomy specimen: Positive
seminal vesicles Gleason 6 and preoperative PSA greater than 18 ng/mL Gleason 7 and
preoperative PSA greater than 14 ng/mL Gleason 8, 9, or 10 and any preoperative PSA
Undetectable PSA (i.e., less than 0.1 ng/mL) within 3 months following radical
prostatectomy and at time of enrollment Negative lymph nodes at time of radical
prostatectomy if lymphadenectomy performed Extracapsular penetration and/or positive
surgical margins allowed
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT
no greater than 2 times ULN Renal: Not specified Cardiovascular: No New York Heart
Association class III or IV cardiac disease or angina pectoris No myocardial infarction
within the past 6 months
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim or sargramostim
except for febrile neutropenia Chemotherapy: No other concurrent chemotherapy Endocrine
therapy: No prior neoadjuvant or adjuvant hormonal therapy for prostate cancer No
concurrent hormonal therapy except for non-disease related conditions (e.g., insulin for
diabetes) No concurrent systemic corticosteriods unless for adrenal insufficiency No
concurrent prednisone, dexamethasone, or other steroidal antiemetics At least 6 months
since prior finasteride No concurrent finasteride No concurrent antiandrogens (e.g.,
flutamide, bicalutamide, nilutamide) or gonadotropin releasing hormone agonists (e.g.,
leuprolide, goserelin) Radiotherapy: No prior adjuvant radiotherapy for prostate cancer No
prior pelvic radiotherapy for prostate cancer Surgery: See Disease Characteristics Other:
At least 6 months since prior saw palmetto No concurrent compounds with 5 alpha-reductase
inhibitor activity (e.g., saw palmetto)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Joseph C. Presti, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Stanford University
Authority:
United States: Federal Government
Study ID:
CDR0000067021
NCT ID:
NCT00003858
Start Date:
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
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