Paclitaxel + Nilotinib for Cancer

Overseen By Andrew M Blakely, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: QT prolonging, CYP3A4 inhibitors

Disqualifiers: Recent surgery, Uncontrolled illness, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

19 Participants Needed

Trial Summary

What is the purpose of this trial?

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 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 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 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 NIH or with their local doctor.

Research Team

Andrew M Blakely, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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.

Inclusion Criteria

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

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.

Exclusion Criteria

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

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

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

Treatment Details

Interventions

• Nilotinib
• Paclitaxel

Trial Overview 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.

Participant Groups

Group I: 1/ IP Catheter Placement and Bidirectional Chemotherapy Experimental Treatment 2 Interventions

IP and IV paclitaxel administration with oral nilotinib

Nilotinib is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Tasigna for:

• Chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib

Approved in United States as Tasigna for:

• Chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adult patients resistant to or intolerant to prior therapy that included imatinib

Approved in Canada as Tasigna for:

• Chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib

Approved in Japan as Tasigna for:

• Chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib

Approved in Switzerland as Tasigna for:

• Chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+