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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022399 |
Purpose
RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer.
PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: celecoxib Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Active Control |
| Official Title: | A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation |
| Study Start Date: | September 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
Patients are followed within 1 month and then at 3 months.
PROJECTED ACCRUAL: A total of 60-70 patients (at least 30 per arm) 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 localized adenocarcinoma of the prostate with one or more of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
At least 24 hours since prior use and no concurrent use of any of the following:
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Study Chair: | Michael A. Carducci, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000068812, JHOC-J0007, JHOC-00030801, NCI-N01-95129, NCI-P01-0186 |
| Study First Received: | August 10, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00022399 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I prostate cancer stage II prostate cancer adenocarcinoma of the prostate |
|
Anti-Inflammatory Agents Celecoxib Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Urogenital Neoplasms Enzyme Inhibitors Genital Diseases, Male Pharmacologic Actions |
Neoplasms Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Prostatic Neoplasms |