Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Ovarian Cancer, Cancer of Ovary, Cancer of the Ovary, Ovary Neoplasms, Primary Peritoneal Carcinoma
In brief
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.
Key facts
- Study ID
- NCT01535157
- Run by
- South Plains Oncology Consortium
- People needed
- 12
- Starts
- 2012-02-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2020-08-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Joe Arrington Cancer Research and Treatment Center — Lubbock, Texas, United States
Full record on ClinicalTrials.gov
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