Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer

A Phase II Evaluation of MGI-114 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

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.

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.

DISEASE CHARACTERISTICS: Histologically confirmed endometrial carcinoma refractory to curative therapy or established treatments Clinically or histologically confirmed persistent or recurrent disease Bidimensionally measurable disease (ascites or pleural effusions not considered measurable) Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No clinically uncontrolled dysrhythmia or signs of ischemia per ECG No congestive heart failure requiring medication No uncontrolled hypertension Other: No significant active infection No other prior or concurrent malignancy within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen allowed (either single or combination cytotoxic drug therapy) No prior 6-hydroxymethylacylfulvene No prior chemotherapy for other malignancy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy for other malignancy Surgery: At least 3 weeks since prior surgery and recovered