Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

South Plains Oncology Consortium

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Ovary Neoplasms; Cancer of the Ovary; Primary Peritoneal Carcinoma; Cancer of Ovary; Ovarian Cancer

Treatments: Drug: Fenretinide/LXS + Ketoconazole

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01535157

SPOC-2011-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Fenretinide/LXS + Ketoconozale

Experimental group

Description:

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.

Treatment:

Drug: Fenretinide/LXS + Ketoconazole