Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer - Full Text View

Sponsor:	OHSU Knight Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00017563

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: docetaxel Drug: mitoxantrone hydrochloride Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Mitoxantrone Mitoxantrone hydrochloride Docetaxel

U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:

Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence. [ Time Frame: Every 3 months after surgery for up to 5 years. ] [ Designated as safety issue: No ]
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.

Enrollment:	57
Study Start Date:	September 2000
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017563

Locations

United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Portland VA Medical Center
Portland, Oregon, United States, 97239

Sponsors and Collaborators

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Tomasz M. Beer, MD

OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00017563 History of Changes
Other Study ID Numbers:	CDR0000068719, OHSU-6082, OHSU-HOR-00037-L, NCI-G01-1962
Study First Received:	June 6, 2001
Results First Received:	May 31, 2011
Last Updated:	August 31, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:

adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Mitoxantrone

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012