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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benaroya Research Institute
• Collaborators: AstraZeneca; Sanofi
• Treatments: Docetaxel; Gefitinib

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