S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms
Intervention: gemcitabine hydrochloride; paclitaxel
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; squamous cell carcinoma of the bladder; adenocarcinoma of the bladder; recurrent urethral cancer; anterior urethral cancer; posterior urethral cancer; urethral cancer associated with invasive bladder cancer; metastatic transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Giving more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in
      treating patients who have advanced or recurrent cancer of the urinary tract.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed urothelial cancer

               -  Transitional cell carcinoma, adenocarcinoma, or squamous carcinoma (bladder,
                  renal pelvis, ureter, or urethra)

          -  Previously untreated metastatic or locoregionally advanced (i.e., bulky pelvic nodes)
             disease OR

          -  Locally recurrent carcinoma after radiotherapy or cystectomy and no longer eligible
             for further radiotherapy or surgery

          -  Measurable disease

        PATIENT CHARACTERISTICS:

        Age:

          -  70 and over OR

          -  Under 60

        Performance status:

          -  Zubrod 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute granulocyte count at least 1,200/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Bilirubin no greater than upper limit of normal (ULN)

          -  Aspartate aminotransferase (SGOT) or alanine aminotransferase (SGPT) no greater than 2
             times ULN

        Renal:

          -  Creatinine no greater than ULN

        Other:

          -  HIV negative

          -  No other concurrent life-threatening medical disorder that would preclude study
             participation

          -  No other prior malignancy within the past 5 years except adequately treated basal cell
             or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer in complete remission

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Prior adjuvant chemotherapy is allowed provided administered more than 10 years ago

          -  No prior gemcitabine, taxanes, or platinum-based adjuvant chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  See Disease Characteristics

          -  At least 28 days since prior radiotherapy and recovered

        Surgery:

          -  See Disease Characteristics

          -  At least 28 days since prior surgery and recovered