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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006124 |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of bladder cancer.
PURPOSE: This randomized phase IIb/III trial is studying celecoxib to see how well it works in preventing disease recurrence in patients who have bladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: celecoxib |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
| Official Title: | Phase IIb/III Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer |
| Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to center and presence of Tis disease (yes vs no). Patients are randomized to one of two arms.
Quality of life is assessed at baseline and at week 54.
Patients are followed at 6 weeks and then every 12 weeks until the last randomized patient has been on the study for 1 year or until disease recurrence.
PROJECTED ACCRUAL: A total of 152 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven superficial transitional cell carcinoma of the bladder at high risk for recurrence, meeting 1 of the following staging criteria:
Must have received the following prior to randomization:
Induction course of BCG comprising 6 weekly intravesical doses (at least 4 doses if BCG intolerant)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Cardiovascular
No history of cardiovascular disease, including any of the following conditions:
Other:
No other prior malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent oral or IV corticosteroids for more than 2 consecutive weeks or orally inhaled corticosteroids for more than 4 consecutive weeks during any 6 month period of the study
Radiotherapy:
Surgery:
Other:
No concurrent chronic NSAIDs except oral cardioprotective dose (no greater than 100 mg/day) of aspirin
Contacts and Locations| United States, Texas | |
| Baylor College of Medicine Comprehensive Cancer Center | |
| Houston, Texas, United States, 77030 | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| Study Chair: | Anita L. Sabichi, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000068139, MDA-ID-99368, NCI-P00-0165, SC-NQ4-99-02-006 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006124 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent bladder cancer |
|
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urinary Bladder Diseases Cyclooxygenase Inhibitors Urinary Bladder Neoplasms Urogenital Neoplasms Enzyme Inhibitors Urologic Neoplasms Pharmacologic Actions |
Neoplasms Neoplasms by Site Urologic Diseases Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |