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Phase IIb/III Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer

Phase 2/Phase 3
18 Years
Not Enrolling
Recurrent Bladder Cancer

Thank you

Trial Information

Phase IIb/III Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer


I. Compare the time to recurrence after treatment with celecoxib vs placebo in patients with
superficial transitional cell carcinoma of the bladder at high risk for recurrence.

II. Correlate the modulation of one or more biomarkers with recurrence of bladder cancer and
confirm the value of the marker(s) as a surrogate endpoint biomarker for bladder cancer and

III. Determine the toxicity of celecoxib in these patients. IV. Compare the quality of life
of patients treated with these regimens.

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.

Arm I: Patients receive oral celecoxib twice daily.

Arm II: Patients receive oral placebo twice daily.

Treatment continues in both arms for 1-2 years in the absence of unacceptable toxicity,
development of recurrent or invasive bladder carcinoma, or development of a second
malignancy requiring radiotherapy or systemic therapy.

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.

Inclusion 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Time to recurrence

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Anita Sabichi

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2000

Completion Date:

April 2008

Related Keywords:

  • Recurrent Bladder Cancer
  • Urinary Bladder Neoplasms



M D Anderson Cancer Center Houston, Texas  77030