Ovarian Cancer Clinical Trial

Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

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.

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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

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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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT01535157

Recruitment Status:

Terminated

Sponsor:

South Plains Oncology Consortium

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There are 3 Locations for this study

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University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
The University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79416, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT01535157

Recruitment Status:

Terminated

Sponsor:


South Plains Oncology Consortium

How clear is this clinincal trial information?

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