Celecoxib in Treating Patients With Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006124
First received: August 3, 2000
Last updated: February 12, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Recurrent Bladder Cancer
Drug: celecoxib
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase IIb/III Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modulation of biomarkers [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Correlation of biomarkers with tumor recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Adverse events as measured by NCI CTC v2.0 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Quality of life as measured by EORTC QLQ-C30 v3.0 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: June 2000
Study Completion Date: April 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006124

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Anita Sabichi M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006124     History of Changes
Other Study ID Numbers: NCI-2009-00869, ID99-368, N01CN85186
Study First Received: August 3, 2000
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014