Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

Phase 2TerminatedNCT01535157

South Plains Oncology Consortium12 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer Cancer of Ovary Cancer of the Ovary Ovary Neoplasms Primary Peritoneal Carcinoma

Interventions

Fenretinide/LXS + KetoconazoleDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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)

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.

Time frame: 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)

Secondary Outcomes

Pharmacokinetics -

Data from ClinicalTrials.gov

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