Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
Key facts
- Study ID
- NCT00186420
- Run by
- Stanford University
- People needed
- 13
- Starts
- 2003-07-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2012-06-13
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Stanford University Cancer Center — Stanford, California, United States
Full record on ClinicalTrials.gov
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