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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Taxotere
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate Cancer, Taxotere

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate the toxicity of taxotere and hormones given adjuvantly.
To measure Quality of Life on this therapy.

Full Information

First Posted
September 13, 2005
Last Updated
June 12, 2012
Sponsor
Stanford University
Collaborators
Aventis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00186420
Brief Title
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Official Title
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Aventis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Taxotere

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Taxotere
Primary Outcome Measure Information:
Title
To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
Time Frame
Following treatment
Secondary Outcome Measure Information:
Title
To evaluate the toxicity of taxotere and hormones given adjuvantly.
Time Frame
Following treatment
Title
To measure Quality of Life on this therapy.
Time Frame
Following treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandy Srinivas, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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