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

NCT ID: NCT00186420

Last Updated: 2012-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2009-09-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Taxotere

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sandy Srinivas

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandy Srinivas, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Cancer Center

Stanford, California, United States

Countries

United States

Other Identifiers

PROS0004

Identifier Type: -

Identifier Source: org_study_id