- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00026091
Fenretinide in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
Phase II Trial of Fenretinide (NSC 374551) in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033-0804
- University of Southern California
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
Given orally
Other Names:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Abdominal Neoplasms
- Ovarian Neoplasms
- Recurrence
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
- Physiological Effects of Drugs
- Antineoplastic Agents
- Protective Agents
- Anticarcinogenic Agents
- Fenretinide
Other Study ID Numbers
- NCI-2013-00457
- PHII-25
- N01CM17101 (U.S. NIH Grant/Contract)
- CDR0000068985 (Registry Identifier: PDQ (Physician Data Query))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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