NCT00084578撤回不适用
A Randomized Trial of Celecoxib and Rosiglitazone, Alone and in Combination, in Patients With Early Stage Non-Invasive Bladder Carcinoma Undergoing Cystoscopic Surveillance and in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Rosiglitazone may help tumor cells develop into normal bladder cells.
PURPOSE: This randomized clinical trial is studying how well giving celecoxib together with rosiglitazone works in treating patients who are undergoing cystoscopic surveillance (screening) for early-stage noninvasive (carcinoma in situ) carcinoma (cancer) of the bladder or radical cystectomy for muscle-invasive carcinoma (cancer has spread into the muscle layer of bladder tissue) of the bladder.
详细描述
OBJECTIVES:
Primary
- Determine whether rosiglitazone and celecoxib, administered alone or in combination, cause changes in the expression of effector molecules, peroxisome proliferator-activated receptor-γ (PPAR-γ) and cyclo-oxygenase-1 (COX-1), in patients with early-stage non-invasive carcinoma of the bladder undergoing cystoscopic surveillance or in patients with muscle-invasive carcinoma of the bladder undergoing radical cystectomy.
Secondary
- Determine whether these regimens result in changes in the expression of downstream effector molecules that mediate cellular proliferation and apoptosis in these patients.
- Determine the relationship between tissue levels of biomarkers of drug effect, proliferation, and apoptosis and the systemic biomarkers of response to treatment, in terms of COX-2 activity and the levels of the endogenous PPAR-γ ligand, in patients treated with these regimens.
- Determine the toxicity of these regimens in these patients.
- Determine the frequency of recurrence and the time to progression in patients undergoing cystoscopic surveillance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically and clinically confirmed bladder cancer
- •Papillary transitional cell carcinoma of the urinary bladder
- •Stage Ta or T1 (grade 1 or 2), N0, M0 disease
- •Must have undergone complete transurethral resection of the bladder within the past 28 days AND/OR
- •Carcinoma in situ of the urinary bladder
- •Stage Tis, N0, M0 disease
- •Must have undergone biopsy within the past 28 days
- •No histological and pathological evidence of invasion of the underlying muscle (stage T2)
- •Muscle-invasive papillary transitional cell carcinoma of the urinary bladder
- •Stage T2-4, NX, M0 disease
- •Intending to undergo radical cystectomy
- •Must have had an upper tract (ureter and renal pelvic) evaluation by intravenous pyelogram, CT scan, or MRI that proved normal within the past year
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC > 4,000/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin < 2 times upper limit of normal (ULN)
- •SGOT and SGPT < 3 times ULN
- •Creatinine ≤ 2.5 mg/dL
- •No other malignancy within the past 3 years except non-invasive bladder cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- •No history of uncontrolled peptic ulcer disease
- •No history of unexplained hypoglycemia
- •No known sensitivity to celecoxib or rosiglitazone
- •No allergy to sulfonamides
- •No history of asthma, urticaria, or allergic reaction after taking aspirin or other NSAIDs
- •No underlying uncontrolled medical illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 months since prior intravesical BCG
- •Chemotherapy
- •No prior intravesical or systemic chemotherapy
- •Endocrine therapy
- •No concurrent insulin
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
- •At least 2 weeks since prior use of non-steroidal anti-inflammatory drugs (NSAIDs) (including COX-2 inhibitors) for more than 3 consecutive days except low-dose (81 mg) aspirin
- •No concurrent beta-blockers
- •No concurrent NSAIDs
- •No other concurrent oral hypoglycemic agents
排除标准
- 未提供
研究者
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