Clinical trial · Interventional
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
NCT00005031CI-TRIAL-00010433completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irofulven | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTSchilder RJ, Blessing JA, Pearl ML, Rose PG. Evaluation of irofulven (MGI-114) in the treatment of recurrent or persistent endometrial carcinoma: A phase II study of the Gynecologic Oncology Group. Invest New Drugs. 2004 Aug;22(3):343-9. doi: 10.1023/B:DRUG.0000026262.77502.31. PMID 15122083