NCT00019552

Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer

A Phase II Study of MGI-114 in Patients With Recurrent or Persistent Epithelial Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.

Detailed description

OBJECTIVES: I. Determine the clinical activity of irofulven in patients with recurrent or persistent ovarian epithelial cancer. II. Characterize the pharmacokinetic profile of this drug in these patients. III. Determine the pharmacodynamic relationship between plasma concentrations and clinical activity or toxicity of this drug in these patients. OUTLINE: Patients are stratified according to the number of prior treatment regimens (1-2 vs 3 or more). Patients receive irofulven IV over 5 minutes on days 1-5. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks until death. PROJECTED ACCRUAL: A maximum of 74 patients will be accrued for this study within 3 years.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	irofulven

Timeline

• Start date: 1998-09-01
• Completion: 2004-04-01
• First posted: 2004-04-13
• Last updated: 2013-06-20

Locations

1 site across 1 country: United States