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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Mitoxantrone

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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Eastern Cooperative Oncology Group(ECOG) 0-2

Life expectancy:

• At least 10 years

Hematopoietic:

• 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

Hepatic:

• 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)

Renal:

• Not specified

Cardiovascular:

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

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

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