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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Paclitaxel

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