Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI OHSU-6082 OHSU-HOR-00037-L, NCI-G01-1962, NCT00017563

Objectives

1. Determine the 5-year freedom from prostate-specific antigen (PSA) recurrence in patients treated with this regimen.
2. Define the maximum tolerated dose of neoadjuvant docetaxel and mitoxantrone followed by prostatectomy in patients with high-risk localized prostate cancer. (Phase I completed as of 2/15/02)
3. Determine the toxicity of this regimen in these patients.
4. Determine the PSA response rate and pathologic response rate in patients treated with this regimen.
5. Determine the clinical response in patients treated with this regimen.
6. Determine the overall survival of patients treated with this regimen.
7. Determine the surgical margin status at time of prostatectomy in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate
  • High-risk, as defined by 1 of the following:
    • Stage T2b (palpable bilateral involvement) or surgically resectable T3
    • PSA 15 ng/mL or greater
    • Gleason grade greater than 4+3 (4+3, 4+4, or 5+any, but not 3+4)



• At least a 50% chance of prostate cancer recurrence within 5 years



• Planned prostatectomy as primary therapy



• No evidence of bone metastases by bone scan



• No evidence of lymph nodes greater than 2 cm on pelvic CT scan (scan required only if PSA greater than 40 ng/mL)

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior cytotoxic chemotherapy
• No other concurrent cytotoxic chemotherapy

Endocrine therapy:

• No prior or concurrent conventional hormonal therapy

Radiotherapy:

• No prior or concurrent radiotherapy (external beam or brachytherapy)

Surgery:

• See Disease Characteristics

Other:

• No prior or concurrent cryotherapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 10 years

Hematopoietic:

• WBC at least 3,000/mm³
• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Conjugated bilirubin no greater than upper limit of normal (ULN)
• Alkaline phosphatase no greater than 4 times ULN
• ALT no greater than 2 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN)

Renal:

• Not specified

Cardiovascular:

• Ejection fraction greater than 50% by MUGA

Other:

• No other malignancy within the past 5 years except nonmelanoma skin cancer
• No significant active medical illness that would preclude study therapy
• No peripheral neuropathy grade 2 or greater
• No hypersensitivity to drugs formulated with polysorbate-80
• No significant contraindications to corticosteroids

Expected Enrollment

A total of 60 patients will be accrued for this study.

Outline

This is a dose-escalation study of mitoxantrone. (Phase I completed as of 2/15/02)

Patients receive neoadjuvant docetaxel and mitoxantrone weekly on weeks 1-3. Treatment repeats once a week for a total of 4 courses.

Patients receive escalating doses of mitoxantrone until the maximum tolerated dose is determined. (Phase I completed as of 2/15/02)

Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy.

Trial Contact Information

Trial Lead Organizations

Oregon Health and Science University Cancer Institute

Tomasz Beer, MD, Protocol chair		Ph: 503-494-3253; 800-494-1234

Registry Information
Official Title		Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients with High Risk Localized Prostate Cancer
Trial Start Date		2000-09-15
Registered in ClinicalTrials.gov		NCT00017563
Date Submitted to PDQ		2001-05-08
Information Last Verified		2004-11-17
NCI Grant/Contract Number		P30-CA69533

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