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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00045097 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with locally advanced or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: ixabepilone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma |
| Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to prior taxane therapy (yes vs no).
Patients (with or without prior taxane exposure) receive ixabepilone IV over 1 hour on days 1-5. An additional cohort of 37 patients who have received prior taxane therapy are then accrued to receive ixabepilone IV over 1 hour on days 1-3 at a higher starting dose. For all patients, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who receive more than 6 courses with satisfactory response may be treated every 4-5 weeks.
Patients removed for unacceptable toxicty are followed periodically.
PROJECTED ACCRUAL: A total of 105 patients (at least 74 with and 21 without prior taxane exposure) will be accrued for this study within 26 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* adenocarcinoma of the breast
No evidence of CNS metastases by brain MRI or contrast head CT scan
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
No concurrent cytochrome p450 3A4 inhibitors, including any of the following:
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Oncology Care Associates | |
| Bethesda, Maryland, United States, 20817 | |
| Suburban Hospital | |
| Bethesda, Maryland, United States, 20814 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | Sandra M. Swain, MD | National Cancer Institute (NCI) |
More Information
| ClinicalTrials.gov Identifier: | NCT00045097 History of Changes |
| Obsolete Identifiers: | NCT00040079 |
| Other Study ID Numbers: | CDR0000256355, NCI-02-C-0229, NCI-5791 |
| Study First Received: | September 6, 2002 |
| Last Updated: | December 13, 2008 |
| Health Authority: | United States: Federal Government |
|
male breast cancer recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |