Kidney Cancer Clinical Trial
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney 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.
Full Description
OBJECTIVES:
Primary
Determine response in patients with locally advanced unresectable or metastatic renal cell carcinoma treated with gemcitabine and irinotecan.
Secondary
Determine the duration of response in patients treated with this regimen.
Determine the tolerance to and toxicity of this regimen in these patients.
Determine median and progression-free survival in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond best response.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 30 months.
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
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There are 2 Locations for this study
Charleston South Carolina, 29425, United States
Spartanburg South Carolina, 29303, United States
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