Trial intelligence / Profile preview

Fenretinide in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma

NCT00026091Phase 2

Key facts

Status: Completed
Start: Sep 2001
Primary completion: Mar 2004
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules

Drugs: fenretinide
Conditions: ovarian epithelial cancerprimary peritoneal carcinoma (PPC)

Overview

Phase 2, open-label, single-arm trial of fenretinide in ovarian epithelial cancer and primary peritoneal carcinoma (PPC), sponsored by National Cancer Institute. Primary endpoint: Response rate (CR or PR) up to 9 years. Started Sep 2001; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Treatment (fenretinide)
Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days.

Who it enrols

Patients with recurrent/metastatic ovarian epithelial or primary peritoneal cancer who have received a platinum and paclitaxel regimen, have measurable disease, and adequate organ function.

Endpoints

Primary

Response rate (CR or PR)Up to 9 years

Secondary

Time to treatment failureUp to 9 years
Duration of responseUp to 9 years
Overall survivalUp to 9 years
ToxicityUp to 9 years after completion of treatment
Pharmacokinetics of fenretinideDay 7 of Courses 4, 8
Molecular changeBaseline to end of treatment

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