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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Taxotere

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00186420

PROS0004

Details and patient eligibility

About

The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.

Enrollment: 13 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)