Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

Sponsor

South Plains Oncology Consortium (Other)

Overall Status

Terminated

CT.gov ID

NCT01535157

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

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

Actual Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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: 4-HPR N-(4-hydroxyphenyl)retinamide Nizoral Feoris

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:

4-HPR

N-(4-hydroxyphenyl)retinamide

Nizoral

Feoris

Outcome Measures

Primary Outcome Measures

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.
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: 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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
2	The University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
3	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