Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:
NCT00186420
First received: September 13, 2005
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.


Condition Intervention Phase
Prostate Cancer
Drug: Taxotere
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy. [ Time Frame: Following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the toxicity of taxotere and hormones given adjuvantly. [ Time Frame: Following treatment ] [ Designated as safety issue: Yes ]
  • To measure Quality of Life on this therapy. [ Time Frame: Following treatment ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: July 2003
Study Completion Date: September 2009
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:

    • Node positive disease post-operatively
    • Capsule involvement
    • Seminal Vesicles involvement
    • Gleason score ≥ 8
    • >50% of core biopsies that are positive
    • Clinical Stage T2c and T3
    • Pre-op PSA > 15 plus Gleason score of 7

      • Age greater than 18
      • ECOG Performance Status 0-1
      • Serum creatinine <= 1.5 mg/dl
      • Granulocyte count >= 1500/m3, Hemoglobin > 8.0 g/dl, and platelet count >= 100,000/m3
      • Total bilirubin <= ULN
      • AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
      • Signed patient informed consent.
      • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.

Exclusion Criteria:

  • Peripheral neuropathy > grade 1
  • History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80.
  • Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.
  • Active infection within 14 days of beginning treatment
  • Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.
  • Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186420

Locations
United States, California
Stanford University Cancer Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Aventis Pharmaceuticals
Investigators
Principal Investigator: Sandy Srinivas, MD Stanford University
  More Information

No publications provided

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00186420     History of Changes
Other Study ID Numbers: PROS0004
Study First Received: September 13, 2005
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Stanford University:
Prostate Cancer
Taxotere

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014