Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
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|ClinicalTrials.gov Identifier: NCT00186420|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 13, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Taxotere||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||September 2009|
- To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy. [ Time Frame: Following treatment ]
- To evaluate the toxicity of taxotere and hormones given adjuvantly. [ Time Frame: Following treatment ]
- To measure Quality of Life on this therapy. [ Time Frame: Following treatment ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186420
|United States, California|
|Stanford University Cancer Center|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sandy Srinivas, MD||Stanford University|
|Responsible Party:||Sandy Srinivas, Associate Professor of Medicine, Stanford University|
|Other Study ID Numbers:||
|First Posted:||September 16, 2005 Key Record Dates|
|Last Update Posted:||June 13, 2012|
|Last Verified:||June 2012|
Genital Neoplasms, Male
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action