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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Cancer of Ovary, Cancer of the Ovary, Ovary Neoplasms, Primary Peritoneal Carcinoma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 2: Progression Free Survival

Outcome Description:

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.

Outcome Time Frame:

From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment)

Safety Issue:

No

Principal Investigator

Jayanthi Lea, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Southwestern Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

SPOC-2011-001

NCT ID:

NCT01535157

Start Date:

February 2012

Completion Date:

June 2014

Related Keywords:

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

Name

Location
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
The University of Texas Southwestern Medical Center Dallas, Texas  75390