Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma
18 Years
N/A
Female
Breast Cancer
Trial Information
Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma
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 from
patients treated with this regimen.
- Determine the dose-limiting toxicity and other major or unusual toxic effects of this
regimen in these patients.
- Determine any antitumor activity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen, including the active metabolite SN-38,
in these patients.
- Correlate pharmacokinetic parameters of this regimen with the biological changes
observed in these patients.
- Determine, preliminarily, the relationship of tumor response with modulation of S-phase
in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan IV over 1.5 hours on days 1, 8, 22, and 29 and oral capecitabine
twice daily on days 1-14 and 23-36. Treatment continues in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 8-37 patients will be accrued for this study within 18-24
months.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Principal Investigator
Tracey O'Connor, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000363790
NCT ID:
NCT00083148
Start Date:
November 2002
Completion Date:
September 2006
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
