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

NCT00026091 | Completed Phase 2

• 4 other identifiers: NCI-2013-00457PHII-25N01CM17101CDR0000068985
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Response rate (CR or PR)

  Associated exact 95% confidence intervals will be calculated.

  Up to 9 years

Secondary Outcomes (6)

• Time to treatment failure

  up to 9 years

• Duration of response

  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

  From first day of treatment to time of death due to any cause, assessed up to 9 years

• Toxicity

  Up to 9 years after completion of treatment

• Pharmacokinetics of fenretinide

  Baseline. day 1, 4 and 7 of courses 1, day 1 of courses 2, 5, and 9, day 7 of courses 4 and 8

Study Arms (1)

Treatment (fenretinide)

EXPERIMENTAL

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

Drug: fenretinide; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

fenretinide DRUG

Given orally

Also known as: fenretinimide, McN-R-1967

Treatment (fenretinide)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (fenretinide)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (fenretinide)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033-0804, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Agustin Garcia

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: March 1, 2004
• Last Updated: March 25, 2013

Record last verified: 2013-02

Locations

US (1)