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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00049244 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: capecitabine Drug: ixabepilone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of BMS-247550 in Combination With Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With a Taxane and an Anthracycline |
| Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups.
Treatment in both groups repeats every 3 weeks for 2-18 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of BMS-247550 and capecitabine until the maximum tolerated dose (MTD) is determined for each group. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Additional patients are treated at the MTD.
Patients are followed for at least 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 34-60 patients will be accrued for this study within 8-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
Must have received prior chemotherapy with a taxane and an anthracycline in the adjuvant or metastatic setting
Measurable or evaluable disease
No active brain metastasis
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent warfarin for therapeutic anticoagulation
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Linnea Chap, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000258052, UCLA-0206011, BMS-CA163-031, NCI-G02-2120 |
| Study First Received: | November 12, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00049244 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent breast cancer stage IV breast cancer |
|
Antimetabolites Capecitabine Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Skin Diseases Antineoplastic Agents Therapeutic Uses Breast Neoplasms Pharmacologic Actions Breast Diseases |