Status:
COMPLETED
Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 di...
Detailed Description
OBJECTIVES: * Determine response to gemcitabine hydrochloride, paclitaxel, and cisplatin (GTP) among patients with regional or distant metastases of transitional cell carcinoma of the urothelium or l...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00310011
Start Date
June 1 1998
End Date
August 1 2009
Last Update
August 10 2018
Active Locations (3)
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1
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, United States, 28203-4239
2
Regional Cancer Center
Greensboro, North Carolina, United States, 27403-1199
3
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096