Mitoxantrone Following Surgery in Treating Patients With Prostate Cancer at High Risk for Recurrence
Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: mitoxantrone hydrochloride (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: Alliance for Clinical Trials in Oncology Official(s) and/or principal investigator(s): Joseph C. Presti, MD, Study Chair, Affiliation: Stanford University
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving chemotherapy after surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of mitoxantrone given after surgery in
treating patients who have prostate cancer that is at high risk for recurrence.
Clinical Details
Official title: A Phase II Trial of Adjuvant Mitoxantrone (NSC #301739) for High Risk Patients Following Radical Prostatectomy
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Decrease in time to failure
Secondary outcome: Decrease in the number of treatment failures
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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)
Locations and Contacts
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: July 7, 2015
|