Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma

The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In addition, researchers would like to determine if the drugs are most effective together or if fenretinide (4-HPR/LXS) is most effective alone.

In this study, an initial Phase I component of six patients will be conducted to monitor for potential toxicities as this wil be the initial adult experience of fenretinide (4-HPR) given together with ketoconazole

Inclusion Criteria:

• Recurrent epithelial ovarian cancer or primary peritoneal carcinoma that can be platinum sensitive or platinum resistant
• SWOG Performance Status 0-2
• Previously received a platinum and paclitaxel containing regimen
• Projected Life Expectancy of at least 3 months
• Adequate bone marrow function
• Adequate organ function
• Must have received at least 1 prior salvage regimen for recurrent ovarian cancer
• Recovery from acute toxicities from surgery, radiation or chemotherapy
• At least 3 weeks from last therapy

Exclusion Criteria:

• Prior fenretinide oral capsule use allowed. If prior IV fenretinide use, must contact study chair for eligibility
• Second malignancy within last 5 years
• Use of concomitant antioxidants, such as vitamin C or E
• Untreated or symptomatic brain metastases
• History of hypertriglyceride levels > 200 mg/dl; triglyceride levels < 200 and receiving treatment are okay.
• Use of certain medications is prohibited - contact study coordinator for information