Study Stopped
drug combination not providing any efficacy. Will use this data in opening new trial
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
1 other identifier
interventional
12
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 ovarian-cancer
Started Feb 2012
Typical duration for phase_1 ovarian-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 3, 2012
CompletedFirst Posted
Study publicly available on registry
February 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 27, 2020
August 1, 2020
5.3 years
February 3, 2012
August 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Phase 2: Progression Free Survival
The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.
From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)
Phase 2: Overall Survival
The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.
From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment)
Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole
Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
From time of first dose to the last (average 6 months)
Phase 2: Event Free Survival
The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.
From enrollment up to the first date of progressive disease or death from any cause (up to 48 months after last patient entered on treatment)
Secondary Outcomes (1)
Pharmacokinetics -
up to 48 months after the last subject enrolled
Study Arms (1)
Fenretinide/LXS + Ketoconozale
EXPERIMENTALOne 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.
Interventions
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79416, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jayanthi Lea, MD
University of Texas Southwestern Medical Center
- STUDY DIRECTOR
Barry J Maurer, MD, PhD
Texas Tech University Health Sciences Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2012
First Posted
February 17, 2012
Study Start
February 1, 2012
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 27, 2020
Record last verified: 2020-08