Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT00019552|
Recruitment Status : Completed
First Posted : April 13, 2004
Last Update Posted : June 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: irofulven||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019552
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Gisele A. Sarosy, MD||National Cancer Institute (NCI)|