SU011248 in Treating Women With Metastatic Breast Cancer That Did Not Respond to Anthracycline or Taxane Chemotherapy
Recruitment status was Active, not recruiting
RATIONALE: SU011248 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU012248 in treating women who have metastatic breast cancer that did not respond to previous chemotherapy that included drugs such as daunorubicin, doxorubicin, epirubicin, docetaxel, or paclitaxel.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Anthracycline- And Taxane-Resistant Metastatic Breast Cancer|
|Study Start Date:||September 2004|
- Determine the antitumor efficacy of SU011248, in terms of objective response rate (confirmed complete or partial response), in women with anthracycline- or taxane-resistant metastatic breast cancer.
- Determine the duration of tumor control and 1-year survival rate of patients treated with this drug.
- Determine the safety of this drug in these patients.
- Correlate plasma concentrations of this drug with efficacy and safety parameters in these patients.
- Correlate potential cancer biomarkers with cancer- and treatment-related outcomes in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral SU011248 once daily on days 1-28. Courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive SU011248 on this protocol or a separate continuation protocol.
Patients are followed at 1 month and then every 2 months for 1 year.
PROJECTED ACCRUAL: A total of 38-63 patients will be accrued for this study.
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Mark D. Pegram, MD||Jonsson Comprehensive Cancer Center|