Clinical trial · Interventional
S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates
NCT00045630CI-TRIAL-00010425completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Urethral Cancer | Malignant Urethral Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine, Paclitaxel, Carboplatin
- description
- Gemcitabine, Paclitaxel, Carboplatin followed by surgery
- interventionNames
- Drug: carboplatin
- Drug: gemcitabine
- Drug: paclitaxel
- Procedure: surgery
Primary outcomes (1)
- measure
- Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy
- timeFrame
- up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )
- description
- Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTdeVere White RW, Lara PN Jr, Goldman B, Tangen CM, Smith DC, Wood DP Jr, Hussain MH, Crawford ED. A sequential treatment approach to myoinvasive urothelial cancer: a phase II Southwest Oncology Group trial (S0219). J Urol. 2009 Jun;181(6):2476-80; discussion 2480-1. doi: 10.1016/j.juro.2009.01.115. Epub 2009 Apr 16. PMID 19371909
- RESULTLara PN, Goldman B, De Vere White R, et al.: A sequential treatment approach to muscle-invasive urothelial cancer: A phase II Southwest Oncology Group trial (S0219) of neoadjuvant paclitaxel, carboplatin, and gemcitabine (PCG). [Abstract] J Clin Oncol 26 (Suppl 15): A-5022, 2008.