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

NCT00151047 | Completed Phase 2 DMC

• 1 other identifier: UMCC 2-42
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who respond to treatment

  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%.

  6 months

Study Arms (1)

Docetaxel and Capecitabine

EXPERIMENTAL

Drug: Capecitabine; Drug: Docetaxel

Interventions

Capecitabine DRUG

Docetaxel and Capecitabine

Docetaxel DRUG

Docetaxel and Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (2)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Capecitabine; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Maha Hussain, MD

  The University of Michigan Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: March 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: October 1, 2007
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

US (2)