Docetaxel Plus Capecitabine in Newly Diagnosed Localized or Locally Advanced Prostate Cancer

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: The purpose of this clinical trial is to look at the chemotherapy combination of docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate cancer, and to determine if this treatment is an acceptable, effective and a safe treatment option. In addition, this clinical trial will evaluate how this treatment affects chemicals (enzymes), and other cancer related genetic changes in the tumor. Optional: This clinical trial will conduct extra imaging studies for research purposes including combined endorectal prostate magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRSI) and diffusion weighted imaging (DWI) to evaluate prostate cancer and response to study treatment.

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

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Capecitabine; Docetaxel

Criteria

Patients must have newly diagnosed prostate cancer with at least one of the following criteria:

• Clinical Stage > T2

• PSA > 15 ng/ml

• Biopsy Gleason's sum > 8

• All patients must have a minimum PSA value of > 5 ng/ml.

• Patients may not have evidence of distant systemic metastasis.

• Patients may not undergo concurrent hormonal, biologic, or chemotherapy.

• Patients may not have prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.

• Patients with a history of severe reaction to docetaxel or other drugs formulated with polysorbate 80 will not be eligible.

• Patients may not have an underlying cardiac disease.