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

NCT ID: NCT00017563

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30

Brief 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.

Detailed Description

OBJECTIVES:

• 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel, Mitoxantrone, Conventional Surgery

Drug: Docetaxel-35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Drug: Mitoxantrone-Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Procedure/Surgery: Conventional Surgery- Prostatectomy will be scheduled 2-4 weeks after the last dose of chemotherapy

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

mitoxantrone hydrochloride

Intervention Type: DRUG

Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

conventional surgery

Intervention Type: PROCEDURE

Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.

Interventions

docetaxel

35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Intervention Type: DRUG

mitoxantrone hydrochloride

Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Intervention Type: DRUG

conventional surgery

Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Tom Beer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz M. Beer, MD

Role: STUDY_CHAIR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Portland VA Medical Center

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-2794

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-HOR-00037-L

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1962

Identifier Type: -

Identifier Source: secondary_id

CDR0000068719

Identifier Type: -

Identifier Source: org_study_id