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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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 >=

- Total bilirubin <= ULN

- AST, ALT and Alkaline Phosphatase must be within the range allowing for

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.

Outcome Time Frame:

Following treatment

Safety Issue:


Principal Investigator

Sandy Srinivas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

July 2003

Completion Date:

September 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Taxotere
  • Prostatic Neoplasms



Stanford University Cancer Center Stanford, California  94305