Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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 persistent or recurrent refractory endometrial cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Irofulven
Criteria
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