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Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Not Recruiting
Trial ID: NCT00186420
Purpose
The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with
high risk prostate cancer after definitive therapy.
Official Title
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
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.
Intervention(s):
drug: Taxotere
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Denise Haas
6507361252