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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fenretinide
laboratory biomarker analysis
pharmacological study
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Ovarian Epithelial Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (fenretinide)

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate (CR or PR)
Associated exact 95% confidence intervals will be calculated.

Secondary Outcome Measures

Time to treatment failure
Estimated using the product-limit method of Kaplan and Meier.
Duration of response
Estimated using the product-limit method of Kaplan and Meier.
Overall survival
Estimated using the product-limit method of Kaplan and Meier.
Toxicity
Tables will be constructed to summarize the observed incidence by severity and type of toxicity.
Pharmacokinetics of fenretinide
Summarized with simple summary statistics: means or medians, ranges, and standard deviations (if numbers and distribution permit).
Molecular change

Full Information

First Posted
November 9, 2001
Last Updated
March 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00026091
Brief Title
Fenretinide in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
Official Title
Phase II Trial of Fenretinide (NSC 374551) in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Primary Peritoneal Cavity Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (fenretinide)
Arm Type
Experimental
Arm Description
Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
fenretinide
Other Intervention Name(s)
fenretinimide, McN-R-1967
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate (CR or PR)
Description
Associated exact 95% confidence intervals will be calculated.
Time Frame
Up to 9 years
Secondary Outcome Measure Information:
Title
Time to treatment failure
Description
Estimated using the product-limit method of Kaplan and Meier.
Time Frame
up to 9 years
Title
Duration of response
Description
Estimated using the product-limit method of Kaplan and Meier.
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
Title
Overall survival
Description
Estimated using the product-limit method of Kaplan and Meier.
Time Frame
From first day of treatment to time of death due to any cause, assessed up to 9 years
Title
Toxicity
Description
Tables will be constructed to summarize the observed incidence by severity and type of toxicity.
Time Frame
Up to 9 years after completion of treatment
Title
Pharmacokinetics of fenretinide
Description
Summarized with simple summary statistics: means or medians, ranges, and standard deviations (if numbers and distribution permit).
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
Title
Molecular change
Time Frame
Baseline to end of treatment

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustin Garcia
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States

12. IPD Sharing Statement

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

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