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Docetaxel in Treating Patients With Relapsed Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Oregon Health and Science University Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00482274
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy.

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete response rate as measured by serum PSA [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to PSA recurrence as seen by 2 measurements performed a week apart [ Designated as safety issue: No ]
  • Time to metastatic disease [ Designated as safety issue: No ]
  • Time to androgen independent state [ Designated as safety issue: No ]
  • Time to death from any cause [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: May 2007
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.

Secondary

  • Determine the time to PSA recurrence in patients receiving this treatment.
  • Determine the time to metastatic disease in patients receiving this treatment.
  • Determine the time to androgen independent state in patients receiving this treatment.
  • Determine the time to death from any cause in patients receiving this treatment.

OUTLINE: This is an open label study.

Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Must have undergone prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy
  • No evidence of metastases on bone scan or CT scan of the abdomen and pelvis
  • Serum testosterone < 50 ng/mL
  • Nadir serum PSA > 0.2 ng/dL after the initiation of androgen deprivation therapy

    • Nadir PSA must be confirmed by the presence of 2 or more subsequent PSA values that are at the same or higher level
    • At least 10% decrease in PSA (or no continued rise) in response to initial androgen-deprivation therapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute granulocyte count ≥ 1,200/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin normal
  • AST ≤ 1.5 times upper limit of normal (ULN) if alkaline phosphatase is not normal
  • Alkaline phosphatase ≤ 5 times ULN if AST and ALT are not normal
  • Creatinine ≤ 2 times ULN
  • No other active malignancy within the past 5 years, except for adequately treated nonmelanoma skin cancer
  • No peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 12 months since initiation of prior androgen-deprivation therapy
  • More than 28 days since prior corticosteroids except for inhaled or topical steroids

    • Stable doses of systemic corticosteroids allowed
  • More than 28 days since prior investigational agents
  • No prior docetaxel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482274

Locations
United States, Oregon
Oregon Health and Science University Cancer Institute Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Tomasz M. Beer, MD     503-494-0365        
United States, Washington
University Cancer Center at University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195-6043
Contact: Clinical Trials Office - University Cancer Center at Universit     206-616-8289        
Sponsors and Collaborators
Oregon Health and Science University Cancer Institute
Investigators
Principal Investigator: Tomasz M. Beer, MD Oregon Health and Science University Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Oregon Health and Science University Cancer Institute ( Tomasz M. Beer )
Study ID Numbers: CDR0000546975, OHSU-2838, OHSU-SOL-06076-LM
Study First Received: June 4, 2007
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00482274  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009