Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
NCT ID: NCT01535157
Last Updated: 2020-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2012-02-29
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fenretinide/LXS + Ketoconozale
One course is defined as 7 days of Fenretinide/LXS + Ketoconazole followed by 14 days of rest. A course is repeated every 21 days if no evidence of disease progression for six courses.
Fenretinide/LXS + Ketoconazole
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
Interventions
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Fenretinide/LXS + Ketoconazole
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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South Plains Oncology Consortium
NETWORK
Responsible Party
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Principal Investigators
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Jayanthi Lea, MD
Role: STUDY_CHAIR
University of Texas Southwestern Medical Center
Barry J Maurer, MD, PhD
Role: STUDY_DIRECTOR
Texas Tech University Health Sciences Center
Locations
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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
Countries
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Related Links
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Click here for more information about the South Plains Oncology Consortium
Other Identifiers
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SPOC-2011-001
Identifier Type: -
Identifier Source: org_study_id
NCT01550692
Identifier Type: -
Identifier Source: nct_alias
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