Back to resultsFenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Primary Purpose
Ovarian Cancer, Cancer of Ovary, Cancer of the Ovary
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fenretinide/LXS + Ketoconazole
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Chemotherapy
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
Sites / Locations
- University of Oklahoma Health Sciences Center
- The University of Texas Southwestern Medical Center
- Joe Arrington Cancer Research and Treatment Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fenretinide/LXS + Ketoconozale
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Pharmacokinetics -
Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations; drug levels in plasma
Full Information
NCT ID
NCT01535157
First Posted
February 3, 2012
Last Updated
August 25, 2020
Sponsor
South Plains Oncology Consortium
1. Study Identification
Unique Protocol Identification Number
NCT01535157
Brief Title
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Official Title
Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
drug combination not providing any efficacy. Will use this data in opening new trial
Study Start Date
February 2012 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South Plains Oncology Consortium
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Cancer of Ovary, Cancer of the Ovary, Ovary Neoplasms, Primary Peritoneal Carcinoma
Keywords
Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fenretinide/LXS + Ketoconozale
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fenretinide/LXS + Ketoconazole
Other Intervention Name(s)
4-HPR, N-(4-hydroxyphenyl)retinamide, Nizoral, Feoris
Intervention Description
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
Primary Outcome Measure Information:
Title
Phase 2: Progression Free Survival
Description
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.
Time Frame
From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)
Title
Phase 2: Overall Survival
Description
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.
Time Frame
From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment)
Title
Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole
Description
Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
Time Frame
From time of first dose to the last (average 6 months)
Title
Phase 2: Event Free Survival
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Pharmacokinetics -
Description
Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations; drug levels in plasma
Time Frame
up to 48 months after the last subject enrolled
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayanthi Lea, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Barry J Maurer, MD, PhD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Study Director
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79416
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.sponc.org
Description
Click here for more information about the South Plains Oncology Consortium
Learn more about this trial
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
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