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



Status:Completed
Conditions:Cancer, Cancer, Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:8/12/2018
Start Date:June 1998
End Date:August 2009

Use our guide to learn which trials are right for you!

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

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.

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.

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
We found this trial at
3
sites
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Greensboro, North Carolina 27403
?
mi
from
Greensboro, NC
Click here to add this to my saved trials