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Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer


- Determine the 5-year freedom from prostate-specific antigen (PSA) recurrence in
patients treated with this regimen.

- 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)

- Determine the toxicity of this regimen in these patients.

- Determine the PSA response rate and pathologic response rate in patients treated with
this regimen.

- Determine the clinical response in patients treated with this regimen.

- Determine the overall survival of patients treated with this regimen.

- Determine the surgical margin status at time of prostatectomy in patients treated with
this regimen.

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.

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

Inclusion Criteria


- 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 computed tomography (CT) scan
(scan required only if PSA greater than 40 ng/mL)



- 18 and over

Performance status:

- Eastern Cooperative Oncology Group(ECOG) 0-2

Life expectancy:

- At least 10 years


- White Blood Cell(WBC) at least 3,000/mm^3

- Neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Conjugated bilirubin no greater than upper limit of normal (ULN)

- Alkaline phosphatase no greater than 4 times ULN

- Alanine transaminase(ALT) no greater than 2 times ULN (1.5 times ULN if alkaline
phosphatase greater than 2.5 times ULN)


- Not specified


- Ejection fraction greater than 50% by Multiple Gated Acquisition(MUGA)scan


- 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


Biologic therapy:

- Not specified


- No prior cytotoxic chemotherapy

- No other concurrent cytotoxic chemotherapy

Endocrine therapy:

- No prior or concurrent conventional hormonal therapy


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


- See Disease Characteristics


- No prior or concurrent cryotherapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.

Outcome Description:

Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA > 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.

Outcome Time Frame:

Every 3 months after surgery for up to 5 years.

Safety Issue:


Principal Investigator

Tomasz M. Beer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage II prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms



OHSU Knight Cancer Institute Portland, Oregon  97239
Portland VA Medical Center Portland, Oregon  97239