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| Sponsored by: |
Oregon Health and Science University |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003781 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Prostate Cancer |
Drug: docetaxel Procedure: pain therapy Procedure: quality-of-life assessment |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Weekly Docetaxel (Taxotere) in Hormone Refractory Metastatic Prostate Cancer |
| Estimated Enrollment: | 25 |
| Study Start Date: | December 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Oregon | |
| Oregon Cancer Center at Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201-3098 | |
| Study Chair: | William D. Henner, MD, PhD | OHSU Knight Cancer Institute |
More Information
| Study ID Numbers: | CDR0000066913, OHSU-5134, OCC-HOR-98037-L, RP-OHSU-5134, NCI-V99-1519 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003781 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer pain |
|
Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Pain |
Genital Diseases, Male Adenocarcinoma Hormones Prostatic Neoplasms Recurrence |
|
Docetaxel Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents |
Therapeutic Uses Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Pharmacologic Actions |
