Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma
Data Collection
Breast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: November 1, 2002
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location