Status:
COMPLETED
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00186420
Start Date
July 1 2003
End Date
September 1 2009
Last Update
June 13 2012
Active Locations (1)
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1
Stanford University Cancer Center
Stanford, California, United States, 94305