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Celecoxib in Treating Patients With Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006124
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 13, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This randomized phase IIb/III trial is studying celecoxib to see how well it works in preventing disease recurrence in patients who have bladder cancer. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of bladder cancer

Condition or disease Intervention/treatment Phase
Recurrent Bladder Cancer Drug: celecoxib Drug: placebo Phase 2 Phase 3

Detailed Description:


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 celecoxib.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Phase IIb/III Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer
Study Start Date : June 2000
Actual Primary Completion Date : March 2006
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Arm I (celecoxib)
Patients receive oral celecoxib twice daily.
Drug: celecoxib
Given orally
Other Names:
  • Celebrex
  • SC-58635

Placebo Comparator: Arm II (placebo)
Patients receive oral placebo twice daily.
Drug: placebo
Given orally
Other Name: PLCB

Primary Outcome Measures :
  1. Time to recurrence [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Modulation of biomarkers [ Time Frame: 3 years ]
  2. Correlation of biomarkers with tumor recurrence [ Time Frame: 3 years ]
  3. Adverse events as measured by NCI CTC v2.0 [ Time Frame: 3 years ]
  4. Quality of life as measured by EORTC QLQ-C30 v3.0 [ Time Frame: Up to 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006124

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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Anita Sabichi M.D. Anderson Cancer Center
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00006124    
Other Study ID Numbers: NCI-2009-00869
N01CN85186 ( Other Grant/Funding Number: US NIH Grant/Contract Award Number )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action