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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00017563
First received: June 6, 2001
Last updated: October 22, 2013
Last verified: October 2013
  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 2

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:


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)
Arms Assigned Interventions
Experimental: 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

Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
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.
Procedure: conventional surgery
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00017563     History of Changes
Other Study ID Numbers: CDR0000068719, OHSU-2794, OHSU-HOR-00037-L, NCI-G01-1962
Study First Received: June 6, 2001
Results First Received: May 31, 2011
Last Updated: October 22, 2013
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014