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OpenTrials
Completed

NCT Number: NCT00005096

Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients.

OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Potential candidate for radical prostatectomy
  • Any of the following:
  • Clinical stage T3 patients
  • Serum PSA at least 20 ng/mL
  • Gleason score 8-10
  • Clinical T2 disease and either of the following:
  • MRI evidence of seminal vesicle involvement
  • Gleason 4+3 cancer with either 5 or 6 biopsies positive
  • CALGB 0-1
  • WBC greater than 3,000/mm3
  • Hematocrit greater than 30%
  • Platelet count greater than 100,000/mm3
  • SGOT, total bilirubin within normal limits
  • Signed Informed consent

Exclusion criteria

  • No prior hormones, radiation or chemotherapy for prostate cancer
  • Evidence of serious active infection

Treatment and study plan

docetaxel

Drug

Other names: Taxotere

Primary outcomes

  1. Complete Response Rate

    Time frame: 2 Months, 6 Months

    Wilcoxon Signed Rank Test

Secondary outcomes

  1. Percentage of Participants with mild to moderate toxicity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • Rhone-Poulenc Rorer

Registry information

Official study title

Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

Important dates

Study start
1999
Primary completion
2002
Study completion
2002
First posted
Mar 4, 2004
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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