Phase 1/11 Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer - Full Text View - ClinicalTrials.gov

 Wiki:  
Fenretinide (4-hydroxy(phenyl)retinamide; 4-HPR) (INN) is a synthetic retinoid deriverative. Retinoids are substances related to vitamin A.

 Wiki:
Ketoconazole ( /ˌkiːtɵˈkoʊnəzɒl/) is a synthetic antifungal drug used to prevent and treat fungal skin infections, especially in immunocompromised patients such as those with AIDS or those on chemotherapy. 

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Criteria

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