Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Sanofi-Aventis
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054509
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Docetaxel may kill any remaining tumor cells following surgery.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have undergone surgery for prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Procedure: adjuvant therapy
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: A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients at High Risk of Relapse Following Prostatectomy

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

Study Start Date: July 2002
Detailed Description:

OBJECTIVES:

  • Determine, preliminarily, the efficacy of docetaxel, in terms of progression-free and 3-year survival rate, in patients with adenocarcinoma of the prostate at high risk of relapse after radical prostatectomy.
  • Determine the time to disease progression in patients treated with this drug.
  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 2 years.

  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* NOTE: *All other variants are excluded
  • No evidence of metastatic prostate cancer by bone scan and chest x-ray
  • Prior prostatectomy within the past 4-8 weeks required

    • Prostate-specific antigen value obtained within 6 months prior to prostatectomy
  • High risk of disease progression

    • Weighted risk of recurrence greater than 2.84

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST/ALT no greater than 1.5 times ULN if alkaline phosphatase no greater than ULN OR
  • Alkaline phosphatase no greater than 4 times ULN if AST and ALT no greater than ULN
  • No acute hepatitis

Renal

  • Creatinine less than 1.5 times ULN
  • No uncontrolled hypercalcemia

Cardiovascular

  • No uncontrolled cardiac arrhythmias
  • No uncontrolled angina
  • No uncompensated congestive heart failure
  • No superior vena cava syndrome

Other

  • Fertile patients must use effective contraception during and for 1 year after study
  • No other prior malignancy except adequately treated nonmelanoma skin cancer or a curatively treated malignancy (including superficial bladder cancer) without evidence of disease for the past 5 years
  • No peripheral neuropathy greater than grade 1
  • No other unstable medical condition
  • No active infection
  • No gastrointestinal bleeding
  • No uncontrolled diabetes
  • No dementia
  • No seizures
  • No psychological, familial, sociological, or geographical condition or other circumstance that would preclude study completion or follow-up
  • No history of hypersensitivity to products containing polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent anticancer biologic therapy

Chemotherapy

  • No prior systemic chemotherapy for prostate cancer
  • No other concurrent systemic anticancer chemotherapy

Endocrine therapy

  • No prior systemic hormonal therapy for prostate cancer
  • No concurrent corticosteroids (except inhaled or topical corticosteroids)
  • No concurrent systemic anticancer hormonal therapy
  • No concurrent dehydroepiandrosterone (DHEA)

Radiotherapy

  • No prior radiotherapy
  • No radiotherapy during and for at least 30 days after study

Surgery

  • See Disease Characteristics

Other

  • No other prior systemic anticancer therapy
  • No prior enrollment into this study
  • No other concurrent alternative therapies including the following:

    • Saw palmetto
    • Lycopene
    • PC-SPES (all types)
  • No other concurrent anticancer therapy
  • No other concurrent systemic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054509

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, New Jersey
Aventis Pharmaceuticals, Incorporated
Bridgewater, New Jersey, United States, 08807-2854
Sponsors and Collaborators
Sanofi-Aventis
  More Information

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

Study ID Numbers: CDR0000270750, AVENTIS-XRP6976J/2501, RPCI-DS-0212
Study First Received: February 5, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00054509  
Health Authority: United States: Federal Government

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

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

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

ClinicalTrials.gov processed this record on January 14, 2009