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Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Prostate Cancer

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Trial Information

Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the response rate associated with capecitabine and docetaxel combination chemotherapy in selected patients with localized or locally advanced prostate cancer.

Principal Investigator

Maha Hussain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2-42

NCT ID:

NCT00151047

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Wayne State UniversityDetroit, Michigan  48202
The University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109