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Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535157
First Posted: February 17, 2012
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
South Plains Oncology Consortium
  Purpose
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.

Condition Intervention Phase
Ovarian Cancer Cancer of Ovary Cancer of the Ovary Ovary Neoplasms Primary Peritoneal Carcinoma Drug: Fenretinide/LXS + Ketoconazole Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by South Plains Oncology Consortium:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • 4-HPR
  • N-(4-hydroxyphenyl)retinamide
  • Nizoral
  • Feoris

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535157


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

Additional Information:
Responsible Party: South Plains Oncology Consortium
ClinicalTrials.gov Identifier: NCT01535157     History of Changes
Obsolete Identifiers: NCT01550692
Other Study ID Numbers: SPOC-2011-001
First Submitted: February 3, 2012
First Posted: February 17, 2012
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by South Plains Oncology Consortium:
Chemotherapy

Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Ketoconazole
Fenretinide
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents