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NCT05185947 · ClinicalTrials.gov registry record · Phase 2
Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer
A Phase 2 study of Colorectal Cancer and Ovarian Cancer, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT05185947: Active Phase 2 study of Colorectal Cancer and Ovarian Cancer, sponsored by National Cancer Institute (NCI).
NCT05185947 is a Phase 2 study of Colorectal Cancer and Ovarian Cancer that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05185947, a Phase 2 study of Colorectal Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Tumors that have spread to the lining of the abdomen from other cancers, such as cancer of the appendix, colon, or ovary, are called peritoneal carcinomatosis. In most cases, outcomes are poor. Researchers want to test a new treatment. Objective: To learn if the combination of oral nilotinib plus paclitaxel given by IV and directly into the abdomen can reduce tumors enough for people to have surgery. Eligibility: Adults aged 18 and older with peritoneal carcinomatosis that is too widespread for surgery. Design: Participants will be screened with: Physical exam Medical history Blood and urine tests Electrocardiogram Laparoscopy. They will get general anesthesia. Small cuts will be made in their abdomen. Tissue and fluid samples will be taken. Surveys about their health CT scans of their torso Participants will have up to 4 more laparoscopies. During the first procedure, a port will be placed under the skin of their abdomen (an IP port). It will be attached to a catheter that is placed in their abdomen. Participants will get treatment in 3-week cycles, for 3 or 6 cycles. They will take nilotinib by mouth twice daily. They will get paclitaxel by IP port (once per cycle) and by IV (twice per cycle). After cycles 3 and 6, they will have a laparoscopy and CT scans. Then they may take nilotinib and get IV paclitaxel for up to 1 year. At study visits, participants will repeat some screening tests. About 6 weeks after treatment ends and then every 3 months for 3 years, participants will have follow-up visits at NIH or with their local doctor.
Primary Outcome
We calculated the rate of downstaging of peritoneal disease burden to become resectable based on PCI score of initial and subsequent laparoscopy, or magnetic resonance imaging and/or computed tomography imaging if laparoscopy is not planned. Disease burden will be considered stable when PCI score at laparoscopy (lap) #3 is \< 4 points higher or lower compared to PCI score at lap #2. Complete Response is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washi
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG Nilotinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-10-13 |
| Est. Completion | 2025-04-04 |
| Phase | Phase 2 |
What the registry record for NCT05185947 still lists
NCT05185947 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower).
The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Paclitaxel is the first listed.
NCT05185947 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05185947 about?
NCT05185947 is a clinical study titled "Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer". Background: Tumors that have spread to the lining of the abdomen from other cancers, such as cancer of the appendix, colon, or ovary, are called peritoneal carcinomatosis. In most cases, outcomes are poor. Researchers want to test a new treatment. Objective: To learn if the combination of oral ni...
What is the current status of trial NCT05185947?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2022-10-13. Estimated completion is 2025-04-04.
What conditions does trial NCT05185947 study?
This clinical trial studies the following conditions: Colorectal Cancer, Ovarian Cancer, Gynecologic Cancer, Colorectal Neoplasms, Ovarian Neoplasms.
What interventions are being tested in trial NCT05185947?
The interventions under investigation include: Paclitaxel (DRUG), Nilotinib (DRUG).
Who is sponsoring clinical trial NCT05185947?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05185947 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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