Ovarian Cancer Clinical Trial
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Summary
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.
Full Description
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
Eligibility 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
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There are 3 Locations for this study
Oklahoma City Oklahoma, 73104, United States
Dallas Texas, 75390, United States
Lubbock Texas, 79416, United States
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