Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma
18 Years
N/A
Both
Kidney Cancer
Trial Information
Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate
Safety Issue:
No
Principal Investigator
Uzair B. Chaudhary, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of South Carolina
Authority:
United States: Federal Government
Study ID:
CDR0000378044
NCT ID:
NCT00089102
Start Date:
September 2003
Completion Date:
July 2009
Related Keywords:
- Kidney Cancer
- recurrent renal cell cancer
- stage III renal cell cancer
- stage IV renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
