Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

August 25, 2020 updated by: South Plains Oncology Consortium

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Texas
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwestern Medical Center
      • Lubbock, Texas, United States, 79416
        • Joe Arrington Cancer Research and Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Fenretinide/LXS + Ketoconazole
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
Other Names:
  • Nizoral
  • 4-HPR
  • N-(4-hydroxyphenyl)retinamide
  • Feoris

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 2: Progression Free Survival
Time Frame: 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.
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
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)
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
Time Frame: 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.
From time of first dose to the last (average 6 months)
Phase 2: Event Free Survival
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics -
Time Frame: 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
up to 48 months after the last subject enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Plains Oncology Consortium

Investigators

  • Study Chair: Jayanthi Lea, MD, University of Texas Southwestern Medical Center
  • Study Director: Barry J Maurer, MD, PhD, Texas Tech University Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2012

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

February 3, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (ESTIMATE)

February 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPOC-2011-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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