Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by South Plains Oncology Consortium
Sponsor:
Information provided by (Responsible Party):
South Plains Oncology Consortium
ClinicalTrials.gov Identifier:
NCT01535157
First received: February 3, 2012
Last updated: June 6, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535157

Contacts
Contact: Amanda K Knight, RN, CCRP 806-743-2690 amanda.knight@ttuhsc.edu

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kelsey Williams    405-271-8001 ext 48657    Kelsey-Williams@ouhsc.edu   
Principal Investigator: Kathleen Moore, MD         
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ying Dong, PhD    214-648-5107      
Contact: Melana Lindsay, MHSA    214-648-3026      
Sub-Investigator: David Miller, MD         
Sub-Investigator: Debra Richardson, MD         
Sub-Investigator: Scott Purinton, MD         
Sub-Investigator: Siobhan Kehoe, MD         
Sub-Investigator: Todd Boren, MD         
Sub-Investigator: Christa Nagel, MD         
Joe Arrington Cancer Research and Treatment Center Not yet recruiting
Lubbock, Texas, United States, 79416
Contact: Dawn Howerton, RN    806-725-8000    dhowerton@covhs.org   
Principal Investigator: Isaac Tafur, MD         
Sub-Investigator: Ibrahim Shalaby, MD         
Sub-Investigator: David Close, MD         
Principal Investigator: Donald Quick, MD         
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:
No publications provided

Responsible Party: South Plains Oncology Consortium
ClinicalTrials.gov Identifier: NCT01535157     History of Changes
Obsolete Identifiers: NCT01550692
Other Study ID Numbers: SPOC-2011-001
Study First Received: February 3, 2012
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

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
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014