Clinical trial NCT01535157: Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Official title: Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Cancer of Ovary
Cancer of the Ovary
Ovary Neoplasms
Primary Peritoneal Carcinoma
Keywords: Chemotherapy
Lead sponsor: South Plains Oncology Consortium
Sponsor class: NETWORK
First posted: 2012-02-17
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Phase 2: Progression Free Survival
timeFrame: From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)
measure: Phase 2: Overall Survival
timeFrame: From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment)
measure: Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole
timeFrame: From time of first dose to the last (average 6 months)
measure: Phase 2: Event Free Survival
timeFrame: 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:
measure: Pharmacokinetics -
timeFrame: up to 48 months after the last subject enrolled
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Jayanthi Lea, MD
role: STUDY_CHAIR
affiliation: Texas Tech University Health Sciences Center
name: Barry J Maurer, MD, PhD
role: STUDY_DIRECTOR
References: