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

March 22, 2013 updated by: National Cancer Institute (NCI)

Phase II Trial of Fenretinide (NSC 374551) in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90033-0804
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Correlative studies
Correlative studies
Other Names:
  • pharmacological studies
Given orally
Other Names:
  • fenretinimide
  • McN-R-1967

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate (CR or PR)
Time Frame: Up to 9 years
Associated exact 95% confidence intervals will be calculated.
Up to 9 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to treatment failure
Time Frame: up to 9 years
Estimated using the product-limit method of Kaplan and Meier.
up to 9 years
Duration of response
Time Frame: From the time measurement criteria met for CR/PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 9 years
Estimated using the product-limit method of Kaplan and Meier.
From the time measurement criteria met for CR/PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 9 years
Overall survival
Time Frame: From first day of treatment to time of death due to any cause, assessed up to 9 years
Estimated using the product-limit method of Kaplan and Meier.
From first day of treatment to time of death due to any cause, assessed up to 9 years
Toxicity
Time Frame: Up to 9 years after completion of treatment
Tables will be constructed to summarize the observed incidence by severity and type of toxicity.
Up to 9 years after completion of treatment
Pharmacokinetics of fenretinide
Time Frame: Baseline. day 1, 4 and 7 of courses 1, day 1 of courses 2, 5, and 9, day 7 of courses 4 and 8
Summarized with simple summary statistics: means or medians, ranges, and standard deviations (if numbers and distribution permit).
Baseline. day 1, 4 and 7 of courses 1, day 1 of courses 2, 5, and 9, day 7 of courses 4 and 8
Molecular change
Time Frame: Baseline to end of treatment
Baseline to end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

March 1, 2004

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 9, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 22, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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