New drug cocktail aims to make inoperable abdominal cancers operable
NCT ID NCT05185947
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested a combination of two drugs—paclitaxel (given intravenously and directly into the abdomen) and oral nilotinib—in 21 adults with cancers that had spread to the lining of the abdomen and could not be surgically removed. The goal was to see if the treatment could shrink the tumors enough to allow surgery. Participants received the drugs in 3-week cycles for up to 6 cycles, with the option to continue for a year. The study measured how many patients became eligible for surgery after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel and nilotinib
- What this could lead to
- If successful, this combination could make inoperable abdominal tumors removable by surgery, potentially improving survival for patients with advanced cancers.
- What could go wrong
- This is a small, early-phase trial with only 21 participants, so results may not apply broadly. The treatment involves significant side effects from chemotherapy and may not shrink tumors enough for surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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21 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Jan 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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