NCT00186420CompletedPhase 2
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
Time Frame: Following treatment
Secondary Outcomes
- To evaluate the toxicity of taxotere and hormones given adjuvantly.(Following treatment)
- To measure Quality of Life on this therapy.(Following treatment)
Investigators
Sandy Srinivas
Associate Professor of Medicine
Stanford University
Study Sites (2)
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