This phase I/II trial studies the side effects and best way to give fenretinide/fenretinide lipid matrix and ketoconazole and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back after previous treatment. Drugs used in chemotherapy, such as fenretinide and fenretinide lipid matrix, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ketoconazole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fenretinide/fenretinide lipid matrix together with ketoconazole may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01535157.
PRIMARY OBJECTIVES:
I. To assess the tolerability of 4-HPR (fenretinide)/LXS oral powder (fenretinide lipid matrix) + ketoconazole given concurrently in patients with recurrent ovarian cancer, fallopian tube cancers or primary peritoneal carcinoma.
II. To determine if 4-HPR/LXS oral powder + ketoconazole given concurrently achieves objective responses in this patient population.
III. To define the two-year progression-free survival (PFS), event-free survival (EFS), and overall survival (OS) for women with recurrent ovarian cancer, fallopian tube cancers or primary peritoneal carcinoma treated concurrently with 4-HPR/LXS oral powder + ketoconazole.
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetics of fenretinide delivered as 4-HPR/LXS oral powder with ketoconazole given concurrently.
II. To determine if PFS, EFS, or OS are associated with 4-HPR exposures > 10uM.
III. To establish cancer cell lines and direct tumor xenografts from patients on the study and to correlate the anticancer activity observed in the patients with activity observed in non-clinical studies using the established cell lines and xenografts.
OUTLINE:
Patients receive fenretinide/fenretinide lipid matrix orally (PO) twice daily (BID) and ketoconazole PO once daily (QD) on days 1-7. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorJayanthi S. Lea
