Phase 2
N=21
Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis
Gynecologic Cancer · Gynecologic Neoplasms · Peritoneal Carcinomatosis · Peritoneal Neoplasms · Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05185947 ↗Enrolled (actual)
21
Serious AEs
42.9%
Results posted
May 2026
Primary outcome: Primary: Proportion of Participants Who Are Successfully Down Staged to Resectable Based on Peritoneal Carcinomatosis Index (PCI) and Principal Investigator (PI) Discretion Reported Along With a 95% Confidence Interval — 0; 0; 0; 0 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel (Drug); Nilotinib (Drug); ECG (Diagnostic_test); CT Scan CAP (Diagnostic_test); Laparoscopy (Procedure); Peritoneal biopsies + ascites washings (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Who Are Successfully Down Staged to Resectable Based on Peritoneal Carcinomatosis Index (PCI) and Principal Investigator (PI) Discretion Reported Along With a 95% Confidence Interval |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Proportion of Participants Who Are Successfully Down-staged to Resectable by Use of Chemotherapy Reported Along With a 95% Confidence Interval. |
0; 0; 0; 0 | — |
| SECONDARY Overall Survival (OS) |
3.63; 11.01; 3.88; 10.45 | — |
| SECONDARY Percent Probability of Peritoneal Progression-free Survival (pPFS) |
75.0; 75.0; 0.0; 0.0; 50.0; 0.0 | — |
| SECONDARY Number of Grades 3, 4, and/or 5 Serious and/or Non-serious Toxicities by Type Assessed Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Participants Quality of Life (QOL) Using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) Instrument |
7.333; 6; 8; 21; 7.333; 21 | — |
| SECONDARY Median Peritoneal Progression-free Survival (pPFS) |
3.779; 3.3580; 2.826; 10.218 | — |
| SECONDARY Percentage of Participants With a Clinicopathologic Response to Therapy by Response Evaluation Criteria in Solid Tumor (RECIST)v 1.1 Reported With a 95% Confidence Interval |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Median Overall Survival (OS) |
3.779; NA; 2.826; 10.218 | — |
| SECONDARY Percentage of Participants Who Become Resectable by Individual Histologies |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Participants Quality of Life (QOL) Using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) Questionnaire |
45.667; 25; 50; 75; 20; 30 | — |
| SECONDARY Clinicopathologic Response to Therapy by Peritoneal Carcinomatosis Index (PCI) Reported for All Participants Along With a 95% Confidence Interval |
0.0; 0.0; 0.0; 1.0; 0.0; 0.0 | — |
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 intravenous (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
Computed tomography (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 intraperitoneal (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 National Institutes of Health (NIH) or with their local doctor.
Eligibility Criteria
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria.
- Histological confirmation of peritoneal carcinomatosis from colorectal, appendiceal, small bowel, gastric, cholangiocarcinoma, breast, ovarian, or other gynecologic (i.e., endometrial, fallopian tube, primary peritoneal, cervical) primary by the Laboratory of Pathology, national Cancer Institute (NCI).
- Participants must have been treated with at least one line of approved systemic chemotherapy, with demonstrated resistance or lack of response
- Measurable or evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. criteria and/or by Peritoneal Carcinomatosis Index (PCI)
- Participants must be assessed to not be candidates for cytoreductive surgery, with laparoscopically assessed Peritoneal Cancer Index (PCI) score thresholds as indicated below:
--Primary Histology PCI Cutoff for Eligibility
- Gastric Total Score >= 10 (out of 39 possible points)
- Others Total Score >= 20 (out of 39 possible points)
- Any Jejunoileal Score >= 4 (out of 12 possible points)
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status = 60%).
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count >= 1,000/mcL
- Platelets >= 100,000/mcL
- Total bilirubin within = 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal calculated using estimated glomerular filtration rate (eGFR)
- Nursing (including breastfeeding) participant must agree to discontinue nursing.
- Individuals of child-bearing potential (IOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 90 days after last study treatment. Should an individual of child-bearing potential suspect to be pregnant while participating in this study, the individual should inform the treating physician immediately.
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Participants must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study.
- Participants who are receiving any other investigational agents or who have received an investigational agent within 30 days prior to the start of study treatment.
- Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs.
- Participants who have received systemic (i.e., oral or intravenous) chemotherapy or other anti-cancer therapy (i.e., immunotherapy) within either 5 half-lives or within 30 days of the last dose of individual agent(s) administered prior to the start of study treatment, whichever is shorter.
- Participants who have undergone major abdominal surgery within the last 12 weeks prior to the start of study treatment.
Note: Exclusion of participants who have undergone major abdominal surgery within the last 12 weeks prior to start of study treatment is to allow for scar tissue formation from that surgery to stabilize. Participant ECOG performance status will be checked to account for prolonged or difficult recoveries from other types of major surgery that would appropriately influence eligibility assessment.
- Participants who have received previous intraperitoneal chemotherapy within the last 6 months prior to the start of study treatment
- Participants requiring the use of drugs known to prolong the QT interval or known to strongly inhibit cytochrome P450 3A4 (CYP3A4), cytochrome P450 CYP (2C8). Participants on such agents at the time of screening are permitted on study if an alternative th
Data sourced from ClinicalTrials.gov (NCT05185947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.