Fenretinide in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer

Completed · Phase 2

Conditions studied: Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Primary Peritoneal Cavity Cancer

In brief

Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

Key facts

Study ID

NCT00026091

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2001-09-01

Last updated by the study team

2013-03-25

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically confirmed recurrent or metastatic epithelial ovarian cancer or primary peritoneal carcinoma
• Unidimensionally measurable disease; indicator lesions must not have been irradiated unless they have grown following radiation therapy
• SWOG performance status 0-2
• Patients must have received a platinum and paclitaxel containing regimen
• Patients are allowed to receive =< 2 prior chemotherapy regimens for recurrent disease; patients who are rechallenged with the same chemotherapy regimen are considered to have had that regimen only once
• Projected life expectancy must be at least 3 months
• Signed informed consent
• Absolute neutrophil count >= 1500/ul
• Platelet count >= 100,000 ul
• Bilirubin =< 2 times the institutional limit of normal
• ALT or AST =< 3 times the upper limit of normal
• Measured or calculated creatinine clearance >= 60 ml/min
• Fasting triglycerides =< 1 time the upper limit of normal; triglycerides may be "normalized" prior to study entry with use of an antilipemic agent (atorvastatin, fenofibrate)
• Patients must have recovered from acute toxicities from surgery, radiation or chemotherapy; at least 3 weeks will have elapsed since any prior therapy directed at the malignant tumor
• Patients of childbearing potential must agree to use an approved method of birth control

You may not qualify if…

• Prior fenretinide is not allowed; prior 13-cis, 9-cis or all-transretinoic acid are allowed
• Patients with a second malignancy within the last 5 years are not allowed, except for those with non-melanomatous skin cancer and carcinoma-in-situ of the cervix; all prior invasive malignancies must be in complete remission
• The use of concomitant antioxidants, such as vitamin C or E, is not allowed
• Patients with concurrent medical, psychological or social conditions of such severity that the investigator deems it unwise to enter the patient on protocol
• Untreated or symptomatic brain metastases
• Pregnant or nursing women

Where it is running

• University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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