A Phase I/II Trial of BAY 43-9006 (Sorafenib) in Combination With Anastrozole in Patients With Metastatic Breast Cancer
PRIMARY OBJECTIVES:
I. Determine the clinical benefit rate of sorafenib in combination with anastrazole in women
with estrogen receptor- and/or progesterone receptor-positive metastatic breast cancer.
II. Determine the recommended phase II dose of sorafenib when administered with anastrozole
in these patients.
SECONDARY OBJECTIVES:
I. Determine the toxic effects of this regimen in these patients. II. Determine the changes
in Raf-MAPK and VEGF-signaling pathways in tumor tissue and stroma before and after
treatment with this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of sorafenib.
PHASE I: Patients receive oral sorafenib twice daily and oral anastrozole once daily on days
1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD.
PHASE II: Patients receive sorafenib at the MTD and anastrozole as in phase I.
After completion of study treatment, patients are followed every 4-8 weeks.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response + Partial Response + Stable Disease > 24 Weeks
Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking. A patient has clinical benefit from treatment if CR + PR + SD > 24 weeks.
24 weeks
No
Claudine Isaacs
Principal Investigator
Lombardi Comprehensive Cancer Center at Georgetown University
United States: Food and Drug Administration
NCI-2009-00069
NCT00217399
June 2005
Name | Location |
---|---|
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |