Celecoxib in Treating Patients With Bladder Cancer
Recurrent Bladder Cancer
About this trial
This is an interventional prevention trial for Recurrent Bladder Cancer
Eligibility Criteria
Criteria: No concurrent radiotherapy No prior angioplasty No concurrent chemotherapy 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 Chronic nasally inhaled steroids allowed provided patient agrees to use mometasone or, in countries where mometasone is not available, fluticasone No prior coronary bypass surgery At least 30 days since prior investigational medication No other prior malignancy within the past 5 years except: No prior pelvic radiotherapy Histologically proven superficial transitional cell carcinoma of the bladder at high risk for recurrence, meeting 1 of the following staging criteria: Stage Ta (grade 3 OR multifocal OR at least 2 occurrences, including current tumor, within the past 12 months) Stage T1 (any grade) Stage Tis Patients with Ta or T1 lesions must have undergone complete transurethral resection of bladder tumor within the past 9 months No carcinoma involving the prostatic urethra or upper urinary tract Must have received the following prior to randomization: Induction course of BCG comprising 6 weekly intravesical doses (at least 4 doses if BCG intolerant) Additional induction courses of BCG allowed Maintenance course of BCG comprising 3 weekly doses (at least 1 dose if BCG intolerant) No evidence of disease by cystoscopy (with or without biopsy) and bladder cytology prior to initiation of maintenance BCG Concurrent interferon allowed Zubrod 0-2 or ECOG 0-2 WBC at least 3,000/mm^3 Hemoglobin at least lower limit of normal Platelet count at least 125,000/Mm^3 No significant bleeding disorder Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 1.5 times ULN No chronic or acute hepatic disorder Creatinine no greater than 1.5 times ULN No chronic or acute renal disorder Normal kidneys and ureters on imaging study within the past 9 months No active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) No active pancreatitis No esophageal, gastric, pyloric channel, or duodenal ulceration that was diagnosed or treated within the past 30 days No history of cardiovascular disease, including any of the following conditions: Stroke Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other medical or psychological condition that would preclude study participation No hypersensitivity or adverse reactions to sulfonamides, cyclooxygenase (COX)-2 inhibitors, salicylates, or other NSAIDs Nonmelanomatous skin cancer cured by excision Carcinoma in situ of the cervix Stage 0 chronic lymphocytic leukemia Other malignancy for which patient has no current evidence of disease, has received no therapy within the past 6 months, has no concurrent or planned therapy, and has an expected disease-free survival of at least 5 years No concurrent immunotherapy At least 2 weeks since prior aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) except cardioprotective dose (no greater than 100 mg/day) of aspirin No concurrent chronic NSAIDs except oral cardioprotective dose (no greater than 100 mg/day) of aspirin Concurrent chronic use is defined as a frequency of at least 3 times per week for more than 2 consecutive weeks per year No other concurrent investigational drug No other concurrent systemic therapy No concurrent lithium or fluconazole No other concurrent hormonal therapy except hormone replacement (i.e., estrogen or thyroid hormone replacement) Myocardial infarction Angina Congestive heart failure
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (celecoxib)
Arm II (placebo)
Patients receive oral celecoxib twice daily.
Patients receive oral placebo twice daily.