Docetaxel in Treating Patients With Stage IV Prostate Cancer

NCT ID: NCT00003781

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-12-31
• Study Completion Date: 2003-06-30

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.

Detailed Description

OBJECTIVES: I. Evaluate the efficacy of weekly docetaxel as measured by disease response, strength and duration of pain reduction, and either a decrease in analgesic use without an increase in pain, or a decrease in PSA, in patients with hormone refractory metastatic prostate cancer. II. Assess the efficacy of this regimen in terms of survival in this patient population. III. Evaluate the effect of this regimen on quality of life in these patients. IV. Determine qualitative and quantitative toxicities of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 15-30 minutes weekly for 6 weeks. Courses repeat every 8 weeks. Therapy continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at weeks 1, 3, 5, and 7 of each course, and a daily pain medication diary is maintained during treatment. Patients are followed for 1 month or until resolution of toxicity, then every 3 months until death.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Conditions

Pain; Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

docetaxel

Intervention Type: DRUG

pain therapy

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Tom Beer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz Beer, MD

Role: STUDY_CHAIR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-5134

Identifier Type: -

Identifier Source: secondary_id

OCC-HOR-98037-L

Identifier Type: -

Identifier Source: secondary_id

RP-OHSU-5134

Identifier Type: -

Identifier Source: secondary_id

NCI-V99-1519

Identifier Type: -

Identifier Source: secondary_id

CDR0000066913

Identifier Type: -

Identifier Source: org_study_id