Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
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.
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: irofulven||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of MGI-114 in Patients With Recurrent or Persistent Epithelial Ovarian Cancer|
|Study Start Date:||September 1998|
|Study Completion Date:||April 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019552
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Gisele A. Sarosy, MD||National Cancer Institute (NCI)|