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

Primary Purpose

Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
gemcitabine hydrochloride
paclitaxel
conventional surgery
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, transitional cell carcinoma of the bladder, regional transitional cell cancer of the renal pelvis and ureter, stage IV bladder cancer, recurrent bladder cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carolinas Hematology-Oncology Associates
  • Regional Cancer Center
  • Wake Forest University Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Response
Response duration
Freedom from progression
Overall survival
Toxicity

Secondary Outcome Measures

Full Information

First Posted
March 29, 2006
Last Updated
August 8, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00310011
Brief Title
Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium
Official Title
A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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 local/regional recurrence after cystoprostatectomy. Determine response in patients who receive GTP as the initial chemotherapeutic treatment as well as in patients who have received prior chemotherapy. Determine response duration, freedom from progression, and overall survival. Assess the toxicity of GTP. OUTLINE: This is an open-label study. Patients are stratified according to prior chemotherapy (yes vs no). Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial response or complete response undergo surgical restaging and debulking. Four to 6 weeks later, patients receive 2 additional courses of chemotherapy. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
Keywords
metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, transitional cell carcinoma of the bladder, regional transitional cell cancer of the renal pelvis and ureter, stage IV bladder cancer, recurrent bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Response
Title
Response duration
Title
Freedom from progression
Title
Overall survival
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank M. Torti, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Carolinas Hematology-Oncology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203-4239
Country
United States
Facility Name
Regional Cancer Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403-1199
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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