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	Treatment or Intervention	Phase
Bladder Cancer Cancer of the Renal Pelvis and Ureter Gastrointestinal Cancer Urethral Cancer	Drug: gemcitabine  Drug: paclitaxel  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

David J. Vaughn, MD,  Study Chair,  University of Pennsylvania Cancer Center   

Study ID Numbers:  CDR0000067810; E-5899
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005644
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08