Bladder Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Study ID:

NCT00005644

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 16 Locations for this study

See Locations Near You

CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07019, United States
Albert Einstein Clinical Cancer Center
Bronx New York, 10461, United States
James P. Wilmot Cancer Center
Rochester New York, 14642, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin, 54301, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee Wisconsin, 53295, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Study ID:

NCT00005644

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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