CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
irofulvendrug
Likely dose
Irofulven IV (specific dose not stated in trial arms)AI-extracted
Key inclusion· 6
  • ✓Histologically confirmed ovarian epithelial or primary peritoneal carcinoma that is recurrent or persistent
  • ✓At least 1 unidimensionally measurable target lesion (≥20 mm by conventional imaging or ≥10 mm by spiral CT)
  • ✓Prior platinum-based chemotherapy (carboplatin, cisplatin, or organoplatinum compound) for primary disease
  • ✓Platinum-sensitive disease with platinum-free interval >6 months but <12 months, with no clinical evidence of progressive disease after response to platinum
Key exclusion· 8
  • ✕Prior congestive heart failure requiring medication
  • ✕Uncontrolled hypertension within the past 6 months
  • ✕History of retinopathy and/or macular degeneration
  • ✕Neuropathy (sensory and motor) greater than grade 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00053365
NCT00053365Phase 2Completed
CompareCT.gov

A Phase II Evaluation Of Irofulven (IND #55804, NSC #683863) In The Treatment Of Recurrent Or Persistent Platinium-Sensitive Ovarian Or Primary Peritoneal Cancer

National Cancer Institute (NCI)·interventional·Posted Jan 28, 2003·Updated Jul 24, 2019

In Brief

A Phase 2 clinical trial evaluating irofulven for Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer. Completed, enrolled 61 participants across 1 site.

Detailed Summary

Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
CountriesUnited States
CollaboratorsGynecologic Oncology Group

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2003
Enrollment StartJun 1, 2003
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 23.4 years ago

Interventions

irofulvendrug

Given IV