Phase I/II Study of Ixabepilone in Combination With the Autophagy Inhibitor Hydroxychloroquine for the Treatment of Patients With Metastatic Breast Cancer
- To determine the recommended phase II dose of ixabepilone and hydroxychloroquine in
patients with metastatic breast cancer. (Phase I)
- To assess the antitumor activity, measured by tumor response rate, in patients who
receive this regimen as a third-line treatment. (Phase II)
- To measure the duration of response for responding patients.
- To measure the time to progressive disease.
- To measure survival time.
- To characterize the quantitative and qualitative toxicities of this regimen in these
- To develop pharmacodynamic markers for autophagy detection in patient specimens.
- To characterize the effects of hydroxychloroquine on autophagy in patients in vivo.
- To investigate whether the estrogen receptor, progesterone receptor, and/or HER2 status
of breast tumors correlates with treatment response.
OUTLINE: This is a multicenter, phase I dose-escalation study of ixabepilone followed by a
phase II study.
During the first course, patients receive ixabepilone IV over 3 hours on day 1 and oral
hydroxychloroquine twice daily on days 3-21. On all subsequent courses, patients receive
ixabepilone IV over 3 hours on day 1 and oral hydroxychloroquine twice daily on days 1-21.
Treatment repeats every 21 days in the absence of disease progression or unacceptable
After completion of study therapy, patients are followed every 6 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose of ixabepilone and hydroxychloroquine
Phase I portion of study
Vassil Karantza-Wadsworth, MD
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Cancer Institute of New Jersey at Hamilton||Hamilton, New Jersey 08690|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|