Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial 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 persistent or recurrent refractory endometrial cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Evaluation of MGI-114 in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
|Study Start Date:||August 2000|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene in patients with persistent or recurrent, refractory endometrial carcinoma. II. Determine the nature and degree of toxicity of this treatment in these patients.
OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-4. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.