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

U

University of Michigan Rogel Cancer Center

Status and phase

Completed
Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Docetaxel
Drug: Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00151047
UMCC 2-42

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Docetaxel and Capecitabine
Experimental group
Treatment:
Drug: Capecitabine
Drug: Docetaxel

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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