Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer



Status:Recruiting
Conditions:Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2012
End Date:June 2017
Contact:Amanda K Knight, RN, CCRP
Email:amanda.knight@ttuhsc.edu
Phone:806-743-2690

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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
We found this trial at
3
sites
Lubbock, Texas 79410
Principal Investigator: Isaac Tafur, MD
Phone: 806-725-8000
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-5107
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Kathleen Moore, MD
Phone: 405-271-8001
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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