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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


N/A
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

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


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.

OUTLINE: This is a randomized, pilot, cohort study. Patients are assigned to 1 of 2 cohorts
according to disease stage (Ta, Tis, T1, N0, M0 vs T2-4, NX, M0).

- Stage 1:

- Cohort 1: Patients receive oral celecoxib twice daily and oral rosiglitazone once
daily for 1 year in the absence of disease progression or unacceptable toxicity.

- Cohort 2: Patients receive oral celecoxib twice daily and oral rosiglitazone once
daily for 14 days. Patients then undergo cystectomy.

- Stage 2: Patients are randomized into 1 of 2 treatment arms.

- Arm I:

- Cohort 1: Patients receive oral celecoxib twice daily for 1 year in the
absence of disease progression or unacceptable toxicity.

- Cohort 2: Patients receive oral celecoxib twice daily for 14 days. Patients
then undergo cystectomy.

- Arm II:

- Cohort 1: Patients receive oral rosiglitazone once daily for 1 year in the
absence of disease progression or unacceptable toxicity.

- Cohort 2: Patients receive oral rosiglitazone once daily for 14 days.
Patients then undergo cystectomy.

Patients in cohort 1 (in both stages) undergo cystoscopic surveillance every 3 months.

PROJECTED ACCRUAL: A total of 120 patients (20 per cohort in study stage 1; 40 per treatment
arm [20 per cohort in each arm] in study stage 2) will be accrued for this study within
12-18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically and clinically confirmed bladder cancer

- Cohort 1

- 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)

- Cohort 2

- 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:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC > 4,000/mm^3

- Platelet count > 100,000/mm^3

Hepatic

- Bilirubin < 2 times upper limit of normal (ULN)

- SGOT and SGPT < 3 times ULN

Renal

- Creatinine ≤ 2.5 mg/dL

Other

- 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

Surgery

- See Disease Characteristics

Other

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Nancy Lewis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000365460

NCT ID:

NCT00084578

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma in Situ

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111