Know Cancer

or
forgot password

A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

Thank you

Trial Information

A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Safety Issue:

No

Principal Investigator

Frank M. Torti, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CCCWFU-88197

NCT ID:

NCT00310011

Start Date:

June 1998

Completion Date:

August 2009

Related Keywords:

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

Name

Location

Carolinas Hematology-Oncology AssociatesCharlotte, North Carolina  28203
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Regional Cancer CenterGreensboro, North Carolina  27403-1199