Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel and cisplatin works in treating patients with advanced transitional cell cancer of the urothelium.

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

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, or ureter) or TCC with squamous or glandular elements

• No pure squamous cell carcinoma or adenocarcinoma

• Disease not amenable to local curative treatment

• Regional or distant metastases of TCC of the urothelium OR local/regional recurrence after cystectomy, cystoprostatectomy, nephroureterectomy, or ureterectomy

• If regional metastases present alone, histological confirmation of the metastases is required

• No clinically evident brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0 or 1

• Granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 10 g/dL

• Creatinine ≤ 1.6 mg/mL

• Bilirubin ≤ 1.8 mg/mL

• SGOT ≤ 3 times upper limit of normal

• Life expectancy > 3 months

• No known sensitivity to E. coli-derived products

• No other prior or concurrent malignancy except active/inactive nonmelanoma skin cancer, adequately treated stage I or II cancer currently in complete remission, or observation-only early-stage prostate cancer

• No other serious medical illness that would limit survival to < 3 months

• No psychiatric condition that would limit compliance with study requirements

• No active uncontrolled bacterial, viral, or fungal infection unless corrected or controlled

• No hemorrhagic disorder

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior systemic chemotherapy regimen

• Prior intravesical therapy allowed

• Prior definitive radiation to renal pelvis, ureter, or bladder allowed

• No concurrent chemotherapy with nonstudy drugs