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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00242918

Run by

Benaroya Research Institute

People needed

29

Starts

2003-05-01

Expected to finish

2007-11-01

Last updated by the study team

2012-02-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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