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Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: June 6, 2001   Last Updated: September 30, 2009   History of Changes
Sponsor: OHSU Knight Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: 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
Procedure: neoadjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
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:


Further study details as provided by OHSU Knight Cancer Institute:

Enrollment: 57
Study Start Date: September 2000
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 CT scan (scan required only if PSA greater than 40 ng/mL)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 10 years

Hematopoietic:

  • 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
  • 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 MUGA

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
Investigators
Study Chair: Tomasz M. Beer, MD OHSU Knight Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: OHSU Knight Cancer Institute ( Tomasz M. Beer, MD )
Study ID Numbers: CDR0000068719, OHSU-6082, OHSU-HOR-00037-L, NCI-G01-1962
Study First Received: June 6, 2001
Last Updated: September 30, 2009
ClinicalTrials.gov Identifier: NCT00017563     History of Changes
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:
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Mitoxantrone
Analgesics
Central Nervous System Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009