Phase 2 N=77 Treatment

S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium

Bladder Cancer · Transitional Cell Cancer of the Renal Pelvis and Ureter · Urethral Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00045630 ↗

Enrolled (actual)

Serious AEs

2.7%

Results posted

May 2013

Primary outcome: Primary: Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy — 46 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: carboplatin (Drug); gemcitabine (Drug); paclitaxel (Drug); surgery (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy	46	—
SECONDARY Overall Survival (OS)	59	—
SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	1; 2; 5; 1; 1; 1	—

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial transitional cell cancer (TCC) of the bladder
Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor volume allowed
The following diagnoses are not allowed:
Small cell carcinoma
Sarcomatoid components
Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT) and a second TURBT performed within 8 weeks of first with attempt to remove all tumor present
Residual disease after second TURBT allowed
No more than 14-56 days after second TURBT
No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis
Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen from one or both TURBTs available

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

White blood cell count (WBC) at least 3,500/mm^3
Absolute granulocyte count at least 1,500/mm^3
Platelet count at least lower limit of normal

Hepatic

Bilirubin no greater than 1.5 mg/dL
Aspartate aminotransferase (SGOT) no greater than 2 times upper limit of normal

Renal

Creatinine no greater than 2.0 mg/dL AND/OR
Creatinine clearance at least 60 mL/min

Other

No prohibitive medical risk that would preclude radical cystectomy
No other serious concurrent systemic disorder that would preclude study compliance
No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease-free for 5 years
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Prior intravesical immunotherapy allowed

Chemotherapy

No prior systemic chemotherapy for TCC of the urothelium
Prior intravesical chemotherapy allowed

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy for TCC of the urothelium
No concurrent radiotherapy

Surgery

See Disease Characteristics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00045630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.