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NCT03736720 · ClinicalTrials.gov registry record · Phase 2
Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT03736720: Clinical Trial Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT03736720 is a Phase 2 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03736720, a Phase 2 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This phase II trial studies how well liposomal irinotecan, leucovorin, and fluorouracil work in treating patients with high grade neuroendocrine cancer of gastrointestinal, unknown, or pancreatic origin that does not respond to treatment and has spread to other places in the body. Lliposomal irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving liposomal irinotecan, leucovorin and fluorouracil may work better in treating patients with neuroendocrine cancer.
Primary Outcome
Will be summarized using frequencies and relative frequencies; with the ORR (= CR+PR / N) estimated using an 80% confidence interval obtained using Jeffrey's prior method. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- PROCEDURE Quality-of-Life Assessment
- DRUG Liposomal Irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2024-08-26 |
| Phase | Phase 2 |
Why NCT03736720 stopped before completion
NCT03736720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Fluorouracil is the first listed.
NCT03736720 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03736720 about?
NCT03736720 is a clinical study titled "Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin". This phase II trial studies how well liposomal irinotecan, leucovorin, and fluorouracil work in treating patients with high grade neuroendocrine cancer of gastrointestinal, unknown, or pancreatic origin that does not respond to treatment and has spread to other places in the body. Lliposomal irinote...
What is the current status of trial NCT03736720?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2019-06-17. Estimated completion is 2024-08-26.
What interventions are being tested in trial NCT03736720?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Quality-of-Life Assessment (PROCEDURE), Liposomal Irinotecan (DRUG).
Who is sponsoring clinical trial NCT03736720?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03736720's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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