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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186420
• Other study ID #: PROS0004
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 12, 2012
• Start date: July 2003
• Est. completion date: September 2009

Study information

• Verified date: June 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2009
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Taxotere

Locations

Country	Name	City	State
United States	Stanford University Cancer Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.		Following treatment	No
Secondary	To evaluate the toxicity of taxotere and hormones given adjuvantly.		Following treatment	Yes
Secondary	To measure Quality of Life on this therapy.		Following treatment	No