Status:
COMPLETED
Safety and Effectiveness Study of Docetaxel and ZD1839 Followed by Removal of the Prostate to Treat Prostate Cancer
Lead Sponsor:
Benaroya Research Institute
Collaborating Sponsors:
AstraZeneca
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00242918
Start Date
May 1 2003
End Date
November 1 2007
Last Update
February 7 2012
Active Locations (1)
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1
Virginia Mason Medical Center
Seattle, Washington, United States, 98101