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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083148 |
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 |
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Breast Cancer |
Drug: capecitabine Drug: irinotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma |
Study Start Date: | November 2002 |
OBJECTIVES:
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.
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
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study ID Numbers: | CDR0000363790, RPCI-RP-0221 |
Study First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00083148 History of Changes |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IV breast cancer |
Antimetabolites Capecitabine Skin Diseases Irinotecan Breast Neoplasms |
Antineoplastic Agents, Phytogenic Camptothecin Breast Diseases Recurrence Carcinoma |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Irinotecan Breast Neoplasms |
Enzyme Inhibitors Camptothecin Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Phytogenic Breast Diseases |