Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Celecoxib in Treating Patients With Bladder Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Prevention	Closed	18 and over	NCI	MDA-ID-99368 NCI-P00-0165, SC-NQ4-99-02-006, NCT00006124

Special Category: NCI Web site featured trial

Objectives

1. 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.
2. 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 celecoxib.
3. Determine the toxicity of celecoxib in these patients.
4. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• No concurrent immunotherapy

Chemotherapy:

• No concurrent 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
  • Chronic nasally inhaled steroids allowed provided patient agrees to use mometasone or, in countries where mometasone is not available, fluticasone
• No other concurrent hormonal therapy except hormone replacement (i.e., estrogen or thyroid hormone replacement)

Radiotherapy:

• No prior pelvic radiotherapy
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• No prior angioplasty
• No prior coronary bypass surgery

Other:

• At least 30 days since prior investigational medication
• 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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

  OR

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Hemoglobin at least lower limit of normal
• Platelet count at least 125,000/mm³
• No significant bleeding disorder

Hepatic:

• 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

Renal:

• 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

Gastrointestinal:

• 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

Cardiovascular

• No history of cardiovascular disease, including any of the following conditions:
  • Myocardial infarction
  • Angina
  • Congestive heart failure
  • Stroke

Other:

• 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
• No other prior malignancy within the past 5 years except:
  • 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

Expected Enrollment

A total of 152 patients will be accrued for this study.

Outcomes

Time to recurrence

Modulation of biomarkers
Correlation of biomarkers with tumor recurrence
Adverse events as measured by NCI CTC v2.0
Quality of life as measured by EORTC QLQ-C30 v3.0

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Anita Sabichi, MD, Protocol chair		Ph: 713-792-6363; 800-392-1611

Related Information

Featured trial article

Registry Information
Official Title		Phase IIb/III Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer
Trial Start Date		2000-07-06
Registered in ClinicalTrials.gov		NCT00006124
Date Submitted to PDQ		2000-07-05
Information Last Verified		2006-02-28
NCI Grant/Contract Number		CA16672, CN85186, CA83639

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