Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: capecitabine Drug: irinotecan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Primary Purpose: Treatment |
| Official Title: | Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma |
| Enrollment: | 12 |
| Study Start Date: | November 2002 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Principal Investigator: | Tracey O'Connor, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Tracey O'Connor, MD, Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00083148 History of Changes |
| Other Study ID Numbers: | CDR0000363790, RPCI-RP-0221 |
| Study First Received: | May 14, 2004 |
| Last Updated: | March 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
recurrent breast cancer stage IV breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Irinotecan Camptothecin Capecitabine Fluorouracil Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013