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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

Must not have

Sensory/motor neuropathy >= Grade 2

More than 3 liters of ascites present at initial laparoscopy, or history of more than two paracentesis procedures in the 30 days prior to initial laparoscopy

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

No Placebo-Only Group

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.

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.

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 below

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My cancer, which started in the peritoneum and is not mucinous, has been confirmed by pathology.

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I cannot have surgery to reduce my tumor, due to extensive spread or involvement.

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My cancer's growth can be tracked with specific medical tests.

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I am 18 years old or older.

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I have had chemotherapy but my cancer did not respond.

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I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I have had a lot of fluid in my abdomen or more than two fluid removal procedures recently.

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I am not taking medication that affects heart rhythm or interferes with certain liver enzymes.

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My liver is severely damaged (Child-Pugh Class C).

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My heart's electrical activity (QTcF interval) is normal or I don't have congenital long QT syndrome.

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I have not had chemotherapy directly into my abdomen in the last 6 months.

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I have HIV with a detectable viral load or take medications that affect heart rhythm or interact with certain enzymes.

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I haven't had chemotherapy or major surgery in the last 12 weeks.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at peritoneal disease relapse from cr or peritoneal disease progression, for up to 3 years after completion of therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Assess clinicopathologic response to therapy

Determine peritoneal progression-free survival (pPFS)

Evaluate participants quality of life (QOL)

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