Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: gemcitabine hydrochloride; irinotecan hydrochloride
Intervention description: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle; 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
Intervention MeSH terms: Gemcitabine; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent renal cell cancer; stage III renal cell cancer; stage IV renal cell 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 unresectable or metastatic kidney cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed renal cell carcinoma

               -  Locally advanced unresectable 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

        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

          -  ALT and AST < 3 times upper limit of normal

          -  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 during and for 6 months after study
             participation

          -  No mental incapacitation or psychiatric illness that would preclude giving informed
             consent

          -  No other active malignancy except nonmelanoma skin cancer

          -  No other severe disease that would preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  At least 4 weeks since prior immunotherapy

          -  No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

        Chemotherapy

          -  No prior chemotherapy

          -  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), or 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