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