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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00310011

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

134

Duration (Months)

23.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter	Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: conventional surgery	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

71 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 1998

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Aug 1, 2009

Outcome Measures

Primary Outcome Measures

Response []
Response duration []
Freedom from progression []
Overall survival []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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