Celecoxib in Treating Patients With Bladder Cancer

NCT00006124 | Completed Phase 2

• 3 other identifiers: NCI-2009-00869ID99-368N01CN85186
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Time to recurrence

  3 years

Secondary Outcomes (4)

• Modulation of biomarkers

  3 years

• Correlation of biomarkers with tumor recurrence

  3 years

• Adverse events as measured by NCI CTC v2.0

  3 years

• Quality of life as measured by EORTC QLQ-C30 v3.0

  Up to 24 months

Study Arms (2)

Arm I (celecoxib)

EXPERIMENTAL

Patients receive oral celecoxib twice daily.

Drug: celecoxib

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive oral placebo twice daily.

Drug: placebo

Interventions

celecoxib DRUG

Given orally

Also known as: Celebrex, SC-58635

Arm I (celecoxib)

placebo DRUG

Given orally

Also known as: PLCB

Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anita Sabichi

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: January 27, 2003
• Study Start: June 1, 2000
• Primary Completion: March 1, 2006
• Study Completion: April 1, 2008
• Last Updated: February 13, 2013

Record last verified: 2013-01

Locations

US (1)