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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00005644

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

85.5

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

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

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Feb 1, 2003

Actual Study Completion Date :

Jun 15, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
2	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
3	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey	United States	07019
4	Albert Einstein Clinical Cancer Center	Bronx	New York	United States	10461
5	James P. Wilmot Cancer Center	Rochester	New York	United States	14642
6	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
7	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
8	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
9	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104
10	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
11	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104
12	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
13	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54301
14	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin	United States	54449
15	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226-3596
16	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin	United States	53295