Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

Phase 1

Terminated

• Conditions: Ovary Neoplasms; Ovarian Cancer; Cancer of Ovary; Primary Peritoneal Carcinoma; Cancer of the Ovary
• Interventions: Drug: Fenretinide/LXS + Ketoconazole

• Registration Number: NCT01535157
• Lead Sponsor: South Plains Oncology Consortium

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

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fenretinide/LXS + Ketoconozale	Fenretinide/LXS + Ketoconazole	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.

Primary Outcome Measures

Name	Time	Method
Phase 2: Event Free Survival	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)	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	From time of first dose to the last (average 6 months)	Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
Phase 2: Progression Free Survival	From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)	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	From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment)	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

Name	Time	Method
Pharmacokinetics -	up to 48 months after the last subject enrolled	Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations; drug levels in plasma

Trial Locations

Locations (3)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Joe Arrington Cancer Research and Treatment Center; 🇺🇸 Lubbock, Texas, United States

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States