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| Sponsor: | OHSU Knight Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00017563 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: docetaxel Drug: mitoxantrone hydrochloride Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| Official Title: | Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer |
| Enrollment: | 57 |
| Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of mitoxantrone. (Phase I completed as of 2/15/02)
Patients receive neoadjuvant docetaxel and mitoxantrone weekly on weeks 1-3. Treatment repeats once a week for a total of 4 courses.
Patients receive escalating doses of mitoxantrone until the maximum tolerated dose is determined. (Phase I completed as of 2/15/02)
Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy.
PROJECTED ACCRUAL: A total of 60 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 confirmed adenocarcinoma of the prostate
High-risk, as defined by 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Oregon | |
| OHSU Knight Cancer Institute | |
| Portland, Oregon, United States, 97239-3098 | |
| Portland VA Medical Center | |
| Portland, Oregon, United States, 97239 | |
| Study Chair: | Tomasz M. Beer, MD | OHSU Knight Cancer Institute |
More Information
| Responsible Party: | OHSU Knight Cancer Institute ( Tomasz M. Beer, MD ) |
| Study ID Numbers: | CDR0000068719, OHSU-6082, OHSU-HOR-00037-L, NCI-G01-1962 |
| Study First Received: | June 6, 2001 |
| Last Updated: | September 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00017563 History of Changes |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer |
|
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions Docetaxel Neoplasms |
Neoplasms by Site Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Mitoxantrone Analgesics Central Nervous System Agents Prostatic Neoplasms |