NCT00084578

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2004

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

July 15, 2013

Status Verified

July 1, 2013

Enrollment Period

2.1 years

First QC Date

June 10, 2004

Last Update Submit

July 12, 2013

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancerstage I bladder cancerstage II bladder cancerstage III bladder cancerstage IV bladder cancertransitional cell carcinoma of the bladder

Interventions

celecoxibDRUG
rosiglitazone maleateDRUG
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

CelecoxibRosiglitazoneNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolidinedionesThiazolesCombined Modality TherapyTherapeutics

Study Officials

  • Nancy Lewis, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

March 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

July 15, 2013

Record last verified: 2013-07