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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
mitoxantrone hydrochloride
conventional surgery
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU Knight Cancer Institute
  • Portland VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel, Mitoxantrone, Conventional Surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
April 26, 2017
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017563
Brief Title
Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
Official Title
Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel, Mitoxantrone, Conventional Surgery
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Description
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
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.
Primary Outcome Measure Information:
Title
Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.
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.
Time Frame
Every 3 months after surgery for up to 5 years.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz M. Beer, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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

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