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

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310011
• Other study ID #: CCCWFU-88197
• Secondary ID: CDR0000466059CCC
• Status: Completed
• Phase: Phase 2
• Start date: June 1998
• Est. completion date: August 2009

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 2009
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Ureteral Neoplasms
• Urinary Bladder Neoplasms

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

• paclitaxel

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Carolinas Hematology-Oncology Associates	Charlotte	North Carolina
United States	Regional Cancer Center	Greensboro	North Carolina
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response
Primary	Response duration
Primary	Freedom from progression
Primary	Overall survival
Primary	Toxicity