Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: gemcitabine hydrochloride; irinotecan hydrochloride
Intervention MeSH terms: Gemcitabine; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: transitional cell carcinoma of the bladder; recurrent bladder cancer; stage III bladder cancer; stage IV bladder cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Combining more than one
      drug may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan
      works in treating patients with locally advanced or metastatic bladder cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed transitional cell carcinoma of the bladder

               -  Locally advanced or metastatic disease

          -  Unidimensionally measurable disease by physical exam or imaging study

               -  The following are not considered measurable disease:

                    -  Bone only disease

                    -  Pleural or peritoneal effusions

                    -  CNS lesions

                    -  Irradiated lesions unless disease progression was documented after
                       radiotherapy

          -  Not amenable to surgery

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin ≤ 2.0 mg/dL

        Renal

          -  Creatinine ≤ 2.0 mg/dL

        Gastrointestinal

          -  No active inflammatory bowel disease

          -  No significant bowel obstruction

          -  No chronic diarrhea

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other active malignancy except nonmelanoma skin cancer

          -  No mental incapacitation or psychiatric illness that would preclude giving informed
             consent

          -  No other severe disease that would preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

        Chemotherapy

          -  No more than 1 prior platinum-based chemotherapy regimen

          -  At least 4 weeks since prior chemotherapy

          -  No prior irinotecan or gemcitabine

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormones except steroids for adrenal failure, hormones for
             non-disease-related conditions (e.g., insulin for diabetes), and intermittent
             dexamethasone as an antiemetic

        Radiotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy

          -  No concurrent palliative radiotherapy

        Surgery

          -  Not specified

        Other

          -  No concurrent participation in another clinical trial