Docetaxel in Treating Patients With Stage IV Prostate Cancer

NCT00003781 | Completed Phase 2 DMC

• 5 other identifiers: CDR0000066913OHSU-5134OCC-HOR-98037-LRP-OHSU-5134NCI-V99-1519
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial of docetaxel in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.

Conditions

Pain; Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer; pain

Interventions

docetaxel DRUG

pain therapy PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV hormone refractory adenocarcinoma of the prostate Symptoms and evidence of disease progression despite standard hormonal therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: At least 3 months Hematopoietic: WBC at least 3000/mm3 Neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT no greater than 2 times ULN (no greater than 1.5 times ULN if alkaline phosphatase is greater than 2.5 times ULN) Alkaline phosphatase no greater than 4 times ULN (no greater than 8 times ULN if known bone involvement and bilirubin and ALT in normal range) Renal: Not specified Other: At least 5 years since any prior malignancy except nonmelanoma skin cancer No other significant medical illness that would prevent compliance No hypersensitivity to drugs formulated with polysorbate-80 Must be able to complete written questionnaires and diaries PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 1 month since prior radiotherapy At least 2 months since prior strontium-89 Surgery: Not specified Other: At least one month since prior investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pain; Prostatic Neoplasms

Interventions

Docetaxel; Analgesia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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; Anesthesia and Analgesia

Study Officials

• Tomasz Beer, MD

  OHSU Knight Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 22, 2004
• Study Start: December 1, 1998
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

US (1)