Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function



Status:Completed
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:1/3/2019
Start Date:May 2000
End Date:June 15, 2007

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

Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients who have advanced cancer of the urothelium with decreased kidney function.

OBJECTIVES:

- Determine the response rate of patients with progressive regional or metastatic
transitional cell carcinoma of the urothelium with renal insufficiency when treated with
paclitaxel and gemcitabine.

- Determine the toxicity of this regimen in this patient population.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV
over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3
courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27
months.

DISEASE CHARACTERISTICS:

- Histologically confirmed progressive regional or metastatic transitional cell
carcinoma of the urothelium

- Mixed histologies containing a component of transitional cell carcinoma allowed

- Bidimensionally measurable disease

- No clinical evidence of CNS metastases

- Clinically unsuspected organ-confined prostate cancer found at time of
cystoprostatectomy allowed

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase
normal OR

- Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR

- SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN

Renal:

- Creatinine no greater than 3.0 mg/dL

- Glomerular filtration rate no greater than 50 mL/min

Cardiovascular:

- No history of American Heart Association class III or IV heart disease

- No uncontrolled congestive heart failure

- No severe cardiac arrhythmias

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No preexisting peripheral neuropathy grade 2 or greater

- No active unresolved infection requiring parenteral antibiotics within the past 7 days

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior systemic biologic response modifier therapy for advanced disease

- Prior intravesical BCG for superficial disease allowed

Chemotherapy:

- Prior intravesical chemotherapy for superficial disease allowed

- No prior chemotherapy for advanced disease

- At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine,
doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV),
or cisplatin as a radiosensitizer

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior major surgery and recovered

Other:

- No concurrent hemodialysis
We found this trial at
16
sites
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Cedar Rapids, Iowa 52403
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
East Orange, New Jersey 07018
?
mi
from
East Orange, NJ
Click here to add this to my saved trials
Fargo, North Dakota 58122
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Kalamazoo, Michigan 49007
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rochester, New York 14642
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Sioux Falls, South Dakota 57104
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Temple, Texas 76508
?
mi
from
Temple, TX
Click here to add this to my saved trials