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

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00186420
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-01
• Study Completion: 2009-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To evaluate the toxicity of taxotere and hormones given adjuvantly.	Following treatment
To measure Quality of Life on this therapy.	Following treatment

Trial Locations

Locations (1)

Stanford University Cancer Center; 🇺🇸 Stanford, California, United States