Celecoxib in Treating Patients With Bladder Cancer

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