Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01535157
• Other study ID #: SPOC-2011-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2012
• Est. completion date: June 2017

Study information

• Verified date: August 2020
• Source: South Plains Oncology Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Other known NCT identifiers

• NCT01550692

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Ovary
• Cancer of the Ovary
• Carcinoma
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Ovary Neoplasms
• Primary Peritoneal Carcinoma

Intervention

Drug:
• Fenretinide/LXS + Ketoconazole
Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day

Locations

Country	Name	City	State
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
South Plains Oncology Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)
Primary	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.	From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment)
Primary	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.	From time of first dose to the last (average 6 months)
Primary	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.	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	Pharmacokinetics -	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

External Links

•   Click here for more information about the South Plains Oncology Consortium