- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00083148
Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma
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 more tumor cells by making tumor cells more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and capecitabine in treating women with advanced breast cancer.
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tracey O'Connor, MD, Roswell Park Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000363790
- RPCI-RP-0221
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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