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

NCT00186420 | Completed Phase 2 DMC

• 1 other identifier: PROS0004
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate Cancer; Taxotere

Outcome Measures

Primary Outcomes (1)

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

  Following treatment

Secondary Outcomes (2)

• To evaluate the toxicity of taxotere and hormones given adjuvantly.

  Following treatment

• To measure Quality of Life on this therapy.

  Following treatment

Interventions

Taxotere DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Stanford University: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

Stanford University Cancer Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Sandy Srinivas, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: September 1, 2009
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

US (1)