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

Not Recruiting

Trial ID: NCT00186420


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
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


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.


drug: Taxotere

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas

New Trial Alerts