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
Sponsor: Gynecologic Oncology Group
This PHASE2 trial investigates Endometrial Cancer and is currently completed. Gynecologic Oncology Group leads this study, which shows 8 recorded versions since 2000 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
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Sep 2025 — Present [monthly]
Completed PHASE2
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Feb 2021 — Jul 2024 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Jan 2021 — Feb 2021 [monthly]
Completed PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Aug 2000
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Gynecologic Oncology Group
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .