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

NCT ID: NCT00026091

Last Updated: 2013-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30

Brief Summary

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

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of fenretinide (4-HPR) in patients with recurrent ovarian cancer or primary peritoneal carcinoma.

II. To assess the toxicity of this agent in this patient population. III. To evaluate molecular changes in normal and tumor cells induced by 4-HPR by studying: (a) the analysis of ceramide and glucosyleceramide levels before and after therapy, (b) intracellular levels of 4-HPR and 4-MPR, and (c) determinants of apoptosis (p53, p21, bcl-2, bax and terminal deoxynucleotidyl transferase [TdT] assay) in baseline tumor specimens, serial serum and tumor biopsy specimens where available, and surrogate in-vitro studies.

IV. To evaluate the pharmacokinetics of fenretinide. V. To further investigate the antiangiogenesis effects of fenretinide in in-vitro assays using ovarian cancer cell lines and in vascular growth factor (VEGF, TGFb) plasma levels in patients.

OUTLINE:

Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Conditions

Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (fenretinide)

Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

fenretinide

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

fenretinide

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

fenretinimide; McN-R-1967; pharmacological studies

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agustin Garcia

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

Other Identifiers

PHII-25

Identifier Type: -

Identifier Source: secondary_id

N01CM17101

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000068985

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2013-00457

Identifier Type: -

Identifier Source: org_study_id