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Mitoxantrone Following Surgery in Treating Patients With Prostate Cancer at High Risk for Recurrence

A Phase II Trial of Adjuvant Mitoxantrone (NSC #301739) for High Risk Patients Following Radical Prostatectomy

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00003858
Enrollment
0
Registered
2004-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Brief 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.

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.

Interventions

DRUGmitoxantrone hydrochloride

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Decrease in time to failureUp to 3 years

Secondary

MeasureTime frame
Decrease in the number of treatment failuresUp to 3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026