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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00242918
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : February 7, 2012
Information provided by:
Benaroya Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Drug: ZD1839 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2003
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. 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 :
  1. Evaluate the toxicity of docetaxel and ZD1839 in patients with high risk, locally advanced prostate carcinoma prior to surgical resection
  2. Clinical Response
  3. Assessment of margin of positivity at surgical resection
  4. Evaluate PSA response from baseline and post treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242918

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United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
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Principal Investigator: Jacqueline Vuky, MD Virginia Mason Medical Center

Additional Information:

Layout table for additonal information Identifier: NCT00242918    
Other Study ID Numbers: BRI 8847
GIA #16134
IIT# 16134
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: June 2006
Keywords provided by Benaroya Research Institute:
High risk
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors