Clinical trial · Interventional
Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis
Phase II 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Appendiceal Cancer | Malignant Appendix Neoplasm | ALIAS | 0.90 |
| Appendiceal Neoplasms | Appendix Neoplasm | ALIAS | 0.90 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Neoplasms |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT Scan CAP | Diagnostic Test | — | UNRESOLVED |
| ECG | Diagnostic Test | — | UNRESOLVED |
| Laparoscopy | Procedure | — | UNRESOLVED |
| Nilotinib | Drug | Nilotinib | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Peritoneal biopsies + ascites washings | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1/ Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy
- description
- Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with oral nilotinib.
- interventionNames
- Drug: Paclitaxel
- Drug: Nilotinib
- Diagnostic Test: ECG
- Diagnostic Test: CT Scan CAP
- Procedure: Laparoscopy
- Procedure: Peritoneal biopsies + ascites washings
Primary outcomes (2)
- measure
- 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
- timeFrame
- Participants were followed from baseline (within 6 weeks prior to the start of treatment), and every 9 weeks during treatment through study completion for 27 months, 14 days
- description
- 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 washings with negative cytology. Partial Response (PR) is at least 4 points decrease in PCI. Progressive Disease (PD) has at least 4 points increase in PCI. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI. To document PCI scoring for each participant, the rubric will be completed following each laparoscopy. The PCI is scaled from 0-39, with higher scores indicating higher disease burden and worse prognosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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 \<= 2 (Karnofsky \>= 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 \<= 1.5x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) \<= 3x institutional ULN, or \<= 5.0x ULN in participants with liver metastases (only) * Serum potassium and magnesium greater than institutional lower limit of normal * Creatinine \<= 1.5 mg/dL or creatinine clearance \>= 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 that does not have the same pharmacokinetic interactions can be found. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Note: No subject will be excluded based on a social situation prior to consultation with the Department of Social Work. * Pregnant individuals are excluded from this study. * Participants with human immunodeficiency virus (HIV) who have detectable viral load, or whose Antiretroviral therapy (ART) contains corrected QT interval (QTc) Prolonging Medications or CYP3A4 Inhibitors regardless of viral load. (NOTE: Participants with HIV who have an undetectable viral load and have been on stable doses of ART that does not prolong the QT interval or is a strong CYP3A4, 2C8 inhibitor are eligible). * QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval of \>= 450 msec at study entry, or congenital long QT syndrome. * More than 3 liters of ascites present at initial laparoscopy, or history of more than two therapeutic paracentesis procedures, each yielding at least 1.5 liters of fluid, in the 30 days prior to initial laparoscopy, or confirmation of predominantly mucinous ascites at the time of screening laparoscopy. * Advanced hepatic failure, as indicated by Child-Pugh Class C cirrhosis. * Sensory/motor neuropathy \>= Grade 2
References
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