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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT00186420
Collaborator
Aventis Pharmaceuticals (Industry)
13
Enrollment
1
Location
74.1
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Study Start Date :
Jul 1, 2003
Actual Primary Completion Date :
Jan 1, 2006
Actual Study Completion Date :
Sep 1, 2009

Outcome Measures

Primary Outcome Measures

  1. To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy. [Following treatment]

Secondary Outcome Measures

  1. To evaluate the toxicity of taxotere and hormones given adjuvantly. [Following treatment]

  2. To measure Quality of Life on this therapy. [Following treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Stanford University Cancer Center Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University
  • Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Sandy Srinivas, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier:
NCT00186420
Other Study ID Numbers:
  • PROS0004
First Posted:
Sep 16, 2005
Last Update Posted:
Jun 13, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Sandy Srinivas, Associate Professor of Medicine, Stanford University
Prostate Cancer
Taxotere
Additional relevant MeSH terms:
Prostatic Neoplasms
Docetaxel

Study Results

No Results Posted as of Jun 13, 2012