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NCT00053365 · ClinicalTrials.gov registry record · Phase 2
Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer
A Phase 2 study of Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT00053365: Completed Phase 2 study of Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, sponsored by National Cancer Institute (NCI).
NCT00053365 is a Phase 2 study of Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 61 participants, below the 100-participant average among 15 other Primary Peritoneal Cavity Cancer trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00053365, a Phase 2 study of Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria: Complete Response is disappearance of all target and non-target lesions; Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable dimensions; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Response is to be evalu
Conditions Studied
Interventions
- DRUG irofulven
Study Locations (1)
Pennsylvania
- Gynecologic Oncology Group - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2003-06 |
| Est. Completion | 2010-07 |
| Phase | Phase 2 |
What the finished NCT00053365 record still lists
NCT00053365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 100-participant average among 15 other Primary Peritoneal Cavity Cancer trials with a reported enrollment target (39% lower).
The record links to 2 conditions, with Primary Peritoneal Cavity Cancer appearing as the primary indexed condition, and to 1 intervention - of which irofulven is the first listed.
NCT00053365 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00053365 about?
NCT00053365 is a clinical study titled "Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer". 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.
What is the current status of trial NCT00053365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2003-06. Estimated completion is 2010-07.
What conditions does trial NCT00053365 study?
This clinical trial studies the following conditions: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer.
What interventions are being tested in trial NCT00053365?
The interventions under investigation include: irofulven (DRUG).
Who is sponsoring clinical trial NCT00053365?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00053365 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Peritoneal Cavity Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00053365's enrollment target sits among peer trials
61 5th of 15 higher than 11 of 15 other Primary Peritoneal Cavity Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Peritoneal Cavity Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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