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Safety and Effectiveness Study of Docetaxel and ZD1839 Followed by Removal of the Prostate to Treat Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Sanofi
Information provided by:
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00242918
First received: October 20, 2005
Last updated: February 3, 2012
Last verified: June 2006
History of Changes
  Purpose

The purpose of this study is to determine the safety and effectiveness of the combination of docetaxel and ZD1839 on destroying prostate cancer before removal of the prostate.


Condition Intervention Phase
Prostate Cancer
 Drug: docetaxel
Drug: ZD1839
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Docetaxel and ZD 1839 (Iressa) Followed by Radical Prostatectomy in Patients With High Risk, Locally Advanced Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Benaroya Research Institute:

Primary Outcome Measures:
  • To evaluate the combination of docetaxel and ZD1839 on pathologic complete response (pCR) in radical prostatectomy specimens. Pathological complete response is defined as no microscopic evidence of neoplastic cells in the resected specimen.

Secondary Outcome Measures:
  • Evaluate the toxicity of docetaxel and ZD1839 in patients with high risk, locally advanced prostate carcinoma prior to surgical resection
  • Clinical Response
  • Assessment of margin of positivity at surgical resection
  • Evaluate PSA response from baseline and post treatment

Estimated Enrollment: 29
Study Start Date: May 2003
Study Completion Date: November 2007
Detailed Description:

It is recognized that there is a subset of patients who are at high risk for progression despite aggressive treatment of localized disease at the time of detection. The critical issue is in addressing micrometastatic disease that has already developed prior to diagnosis. This study utilizes daily doses of ZD1839 and weekly docetaxel for two cycles prior to radical prostatectomy.

ZD1839 has demonstrated antiproliferative activity against human tumor xenografts and in coadministration with cytotoxic agents against prostate cell lines (PC-3 and TSU-PRI). The combination of ZD1839 and docetaxel has been reported to be feasible with an acceptable toxicity profile.

This phase II, single center trial is specifically targeting those patients with high-risk adenosarcoma of the prostate.

  Eligibility

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

Inclusion Criteria:

  • prostate carcinoma: clinical stage T2b-3 or serum PSA>20 ng/ml or Gleason sum score 8-10.
  • clinical T2 patients are eligible if endorectal coil MRI shows T3 disease, or Gleason 4+3 cancer in 5 or more biopsies (minimum of 10 biopsies total required)
  • ECOG performance status of 0, 1 or 2
  • adequate hematological, liver and renal function
  • existing peripheral neuropathy < grade 1
  • ability to tolerate oral medications.

Exclusion Criteria:

  • Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer
  • any major surgery within four weeks
  • prior hormonal therapy (except finasteride for obstructive voiding symptoms- -evidence of metastatic disease, confirmed by physical examination, computed tomography of the abdomen and pelvis within 45 days and by bone scan within 60 days of signing informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242918

Locations
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
AstraZeneca
Sanofi
Investigators
Principal Investigator: Jacqueline Vuky, MD Virginia Mason Medical Center
  More Information

Additional Information:
Benaroya Research Institute at Virginia Mason is dedicated to discovering the causes of and cures for autoimmune and genetic diseases, to benefit patients with conditions such as diabetes, arthritis, and cancer.  This link exits the ClinicalTrials.gov site
Virginia Mason Medical Center is a private, non-profit organization offering a system of integrated health services.  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00242918     History of Changes
Other Study ID Numbers: BRI 8847, GIA #16134, 1839US/290, IIT# 16134
Study First Received: October 20, 2005
Last Updated: February 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Benaroya Research Institute:
High risk
adenocarcinoma
prostate cancer
neoadjuvant

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
 Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013