Status:
COMPLETED
Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help capecitabine kill ...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of capecitabine and irinotecan in women with advanced breast cancer. * Determine the degree of accumulation of cells in S-phase in tumor biopsies fr...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer not eligible for potentially curative therapy or studies of higher priority
- Advanced disease
- Tumor accessible to biopsy AND not irradiated
- Failed at least 1 prior chemotherapy regimen (not including adjuvant chemotherapy)
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- ECOG 0-2
- Life expectancy
- At least 3 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Hepatic
- AST ≤ 2 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 50 mL/min
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active uncontrolled bacterial, viral, or fungal infection
- No poor medical risk from non-malignant systemic disease
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- Prior irinotecan allowed
- Prior carboplatin allowed
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy except for small port radiotherapy for local control
- Surgery
- More than 4 weeks since prior major surgery
- Other
- No concurrent high-dose IV cyclosporine
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00083148
Start Date
November 1 2002
End Date
September 1 2006
Last Update
March 9 2011
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001