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Phase II Study of Weekly Docetaxel (Taxotere) in Hormone Refractory Metastatic Prostate Cancer

Phase 2
18 Years
Not Enrolling
Pain, Prostate Cancer

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Trial Information

Phase II Study of Weekly Docetaxel (Taxotere) in Hormone Refractory Metastatic Prostate Cancer

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

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.

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Tomasz Beer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Federal Government

Study ID:




Start Date:

December 1998

Completion Date:

June 2003

Related Keywords:

  • Pain
  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • pain
  • Prostatic Neoplasms



OHSU Knight Cancer Institute Portland, Oregon  97239