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Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate (2007-5904)
This study is currently recruiting participants.
Verified by University of California, Irvine, February 2009
First Received: January 10, 2008   Last Updated: February 11, 2009   History of Changes
Sponsors and Collaborators: University of California, Irvine
Sanofi-Aventis
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00598858
  Purpose

The purpose of this research study is to evaluate the response to docetaxel in patients with stage I/II prostate cancer, who are scheduled for prostatectomy.

Patients will receive docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day for a total of 3 cycles. Patients will be treated for approximately two months. At a baseline visit, patients will have endorectal MRI, digital rectal examination, complete chemistries, pathological diagnosis, and serum testosterone and prostate-specific antigen level measurements.

Patients will be seen every three week for assessment of toxicity, physical examination, and complete blood count. Once a month, patients will have repeat digital rectal examination, complete chemistries, and serum testosterone and prostate-specific antigen level measurements. After 3 cycles of chemotherapy, patients will be reevaluated with endorectal MRI and serum PSA and then be proceeded to radical prostatectomy.


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel plus prednisone
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Prednisone Docetaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Pilot Phase II Study to Determine the Effects of Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate in Patients Who Are Scheduled for Radical Prostatectomy With Genomic Correlates of Pathological Response

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To evaluate PSA response to neoadjuvant docetaxel in patients with stage I /II prostate cancer, who are scheduled for prostatectomy. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify potential gene expression patterns in the prostate that may predict the response of neoadjuvant docetaxel. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day for a total of 3 cycles
Drug: Docetaxel plus prednisone
Docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day for a total of 3 cycles

  Eligibility

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

Inclusion Criteria:

  • Patient must have a histological diagnosis of adenocarcinoma of the prostate which is measurable or evaluable Stage I or II.
  • Patient must have an ECOG performance status 0-2.
  • Patient must have a pre-study PSA within 28 days prior to start of therapy.
  • Patients who have received prior radiotherapy are not eligible.
  • Patient must have an adequate renal function
  • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
  • Age > 18
  • Patients must be able to take oral medications

Exclusion Criteria:

  • Patients with measurable metastatic diseases by a CT scan of the abdomen and pelvis within 28 days and by a bone scan within 42 days prior to start of therapy.
  • Patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
  • Patients must not be treated with non-steroidal anti-androgens (flutamide, bicalutamide, nilutamide or ketoconazole).
  • Patients must not take vitamins, herbs, or micronutrient supplement within 28 days prior to start of therapy.
  • Patients may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.
  • Patients should not have any medical life-threatening complications of their malignancies
  • Patients should not have a known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV).
  • Patients should not have current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
  • Patients with history of myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within 6 months
  • Patients with clinically significant peripheral vascular disease
  • Patients with evidence of bleeding diathesis or coagulopathy
  • Patients with central nervous system or brain metastases
  • Patients who had major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  • Patients with minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
  • Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
  • Patients with serious, non-healing wound, ulcer, or bone
  • Patients who are diagnosed of any other malignancy except non-melanomatous skin cancer in the past 5 years
  • Patients receiving anticoagulation therapy (e.g. Coumadin) prior to registration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598858

Contacts
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center 1-877-UC-STUDY UCstudy@uci.edu

Locations
United States, California
Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center     877-827-8839     UCstudy@uci.edu    
Sponsors and Collaborators
University of California, Irvine
Sanofi-Aventis
Investigators
Principal Investigator: John Fruehauf, MD Chao Family Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of California, Irvine - Chao Family Comprehensive Cancer Center ( John Fruehauf, MD )
Study ID Numbers: UCI 07-14
Study First Received: January 10, 2008
Last Updated: February 11, 2009
ClinicalTrials.gov Identifier: NCT00598858     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
prostate cancer
Prostatectomy

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Glucocorticoids
Hormones
Docetaxel
Prostatic Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009