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Tyrosine Kinase Inhibitor
Paclitaxel + Nilotinib for Cancer
Phase 2
Recruiting
Led By Andrew M Blakely, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological confirmation of non-mucinous peritoneal carcinomatosis from specified primary sources by the Laboratory of Pathology, NCI
Assessed to not be candidates for cytoreductive surgery, with PCI score > 30 on screening laparoscopy or with extensive small bowel serosal involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at peritoneal disease relapse from cr or peritoneal disease progression, or death, for up to 3 years after completion of therapy
Awards & highlights
Study Summary
This trial is testing a combination of oral nilotinib plus paclitaxel given by IV and directly into the abdomen to see if it can reduce tumors enough for people to have surgery.
Who is the study for?
Adults over 18 with peritoneal carcinomatosis from certain cancers, not suitable for surgery due to widespread disease. Must have tried at least one chemotherapy without success and be physically able to participate (ECOG <=2). They should have functioning organs and marrow, agree to use contraception if applicable, and not breastfeed during the trial.Check my eligibility
What is being tested?
The study is testing a new treatment combining oral nilotinib with paclitaxel administered intravenously (IV) and directly into the abdomen (IP) in hopes of shrinking tumors enough for surgery. Participants will undergo multiple cycles of this treatment along with regular health assessments including laparoscopies.See study design
What are the potential side effects?
Potential side effects include reactions related to IV/IP administration of paclitaxel such as abdominal pain or complications, allergic reactions, nerve issues like numbness or tingling (neuropathy), fatigue, blood count changes increasing infection risk, heart rhythm problems due to nilotinib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer, which started in the peritoneum and is not mucinous, has been confirmed by pathology.
Select...
I cannot have surgery to reduce my tumor, due to extensive spread or involvement.
Select...
My cancer's growth can be tracked with specific medical tests.
Select...
I am 18 years old or older.
Select...
I have had chemotherapy but my cancer did not respond.
Select...
I can take care of myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, at peritoneal disease relapse from cr or peritoneal disease progression, for up to 3 years after completion of therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at peritoneal disease relapse from cr or peritoneal disease progression, for up to 3 years after completion of therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate efficacy of bidirectional chemotherapy using intraperitoneal and intravenous paclitaxel and oral nilotinib by calculating the rate of downstaging of peritoneal disease burden to become resectable, based on Peritoneal Carcinomatosis Inde...
Secondary outcome measures
Assess clinicopathologic response to therapy
Determine peritoneal progression-free survival (pPFS)
Evaluate participants quality of life (QOL)
+3 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/ IP Catheter Placement and Bidirectional ChemotherapyExperimental Treatment2 Interventions
IP and IV paclitaxel administration with oral nilotinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Nilotinib
2005
Completed Phase 4
~2670
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,667 Previous Clinical Trials
40,926,062 Total Patients Enrolled
13 Trials studying Peritoneal Carcinomatosis
413 Patients Enrolled for Peritoneal Carcinomatosis
Andrew M Blakely, M.D.Principal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
460 Total Patients Enrolled
1 Trials studying Peritoneal Carcinomatosis
60 Patients Enrolled for Peritoneal Carcinomatosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe numbness, tingling, or pain in my hands or feet.My cancer, which started in the peritoneum and is not mucinous, has been confirmed by pathology.I have had a lot of fluid in my abdomen or more than two fluid removal procedures recently.I cannot have surgery to reduce my tumor, due to extensive spread or involvement.My cancer's growth can be tracked with specific medical tests.I am not taking medication that affects heart rhythm or interferes with certain liver enzymes.My liver is severely damaged (Child-Pugh Class C).I agree to use birth control during and for 3 months after the study.My heart's electrical activity (QTcF interval) is normal or I don't have congenital long QT syndrome.I have not had chemotherapy directly into my abdomen in the last 6 months.My organs and bone marrow are working well.I have HIV with a detectable viral load or take medications that affect heart rhythm or interact with certain enzymes.I haven't had chemotherapy or major surgery in the last 12 weeks.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am 18 years old or older.I have had chemotherapy but my cancer did not respond.I can take care of myself but may not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: 1/ IP Catheter Placement and Bidirectional Chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Paclitaxel a secure option for individuals?
"Paclitaxel received a safety score of 2 due to existing evidence in Phase 2 trials that demonstrate its security, but no proof yet demonstrating the medication's efficacy."
Answered by AI
What is the aggregate figure of participants enrolled in this trial?
"Affirmative. According to the clinicaltrials.gov website, this medical experiment is currently in search of participants and was first posted on October 13th 2022. The study has since been revised as recently as October 28th 2022, with 70 people needed at one location for it's completion."
Answered by AI
Are applications for this medical research still being accepted?
"Yes, the information accessible from clinicaltrials.gov confirms that this medical exploration is presently recruiting patients. The trial was initially published on October 13th 2022 and had changes applied to it most recently in late October of the same year. 70 individuals are required for participation at a single site."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Texas
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- National Institutes of Health Clinical Center: < 24 hours
Average response time
- < 1 Day
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