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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Aventis Pharmaceuticals
• Treatments: Docetaxel

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.