A study to test whether a product called celecoxib will help to stop bladder cancer returning

Phase 1

• Conditions: on-muscle Invasive Transitional cell Carcinoma of the Bladder; MedDRA version: 20.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-000687-89-GB
• Lead Sponsor: Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-23
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

1.Primary or recurrent superficial TCC of the bladder of intermediate or high risk of recurrence.
2.Age > 18
3.WHO performance status 0, 1 or 2
4.No evidence of upper tract TCC on imaging studies within the past 36 months or before randomisation
5.Pre-treatment haematology and biochemistry values within acceptable limits.6.Negative pregnancy test for women of child-bearing potential
7.At least 2 months since prior celecoxib or NSAIDs (other than low dose aspirin (<=150mg daily)
8.Baseline ECG showing no evidence of established or acute ischaemic heart disease and normal clinical cardiovascular assessment
9.Written informed consent and available for long-term follow-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Low risk of recurrence TCC of the bladder
2.Carcinoma involving the prostatic urethra or upper urinary tract
3.>=T2 TCC or previous history of>=T2
4.Significant bleeding disorder
5.Chronic or acute renal disorder
6.Oesophageal gastric, pyloric channel, or duodenal ulceration diagnosed or treated within the past 30 days
7.Active or previous peptic ulceration or gastrointestinal bleeding in the last year
8.Inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis)
9.Pancreatitis
10.Pregnant or lactating women or patients of childbearing potential unwilling or unable to use adequate non-hormonal contraception.
11.Hypersensitivity or adverse reactions to sulfonamides, COX-2 inhibitors, salicylates, or other NSAIDs
12.On current or planned chronic NSAIDs therapy (except low dose aspirin <= 150 mg once daily). Chronic use of NSAIDs is defined as a frequency of 1 or more a day, for more than 50 consectutive days in a year.
13.Regular use of low-dose celecoxib within the previous 8 weeks.
14.Current or long-term use of corticosteroids
15.Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease, previous history of myocardial infarction, coronary artery bypass graft, invasive coronary revascularization or angina, uncontrolled arterial hypertension (ie BP >180/110mmHg under treatment with two anti-hypertensive drugs), rhythm abnormalities requiring permanent treatment. ECG should be within limits prior to starting trial therapy.
16.Patients with diabetes controlled by diet and oral medication are eligible for the study; however patients treated with insulin will be excluded.
17.Past history of stroke/TIA, symptomatic peripheral vascular disease.
18.Other malignancy within the past 5 years, except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCIS of the breast.
19.Concurrent chemotherapy other than intravesical MMC
20.Psychiatric or addictive disorders which could preclude obtaining informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified