Working… Menu
Trial record 43 of 278 for:    prostate cancer AND localized | ( Map: United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151047
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Capecitabine Drug: Docetaxel Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer
Study Start Date : March 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Docetaxel and Capecitabine Drug: Capecitabine
Drug: Docetaxel

Primary Outcome Measures :
  1. The percentage of patients who respond to treatment [ Time Frame: 6 months ]
    To evaluate the response rate associated with capecitabine and docetaxel combination chemotherapy in selected patients with localized or locally advanced prostate cancer. Response is defined as a reduction in the PSA (Prostate Specific Antigen) by at least 50%.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00151047

Layout table for location information
United States, Michigan
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Layout table for investigator information
Principal Investigator: Maha Hussain, MD The University of Michigan Comprehensive Cancer Center

Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center Identifier: NCT00151047     History of Changes
Other Study ID Numbers: UMCC 2-42
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Diseases, Male
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic