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Protocol Details

Phase II Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis from Colorectal, Appendiceal, Small Bowel, Gastric, Ovarian, or Other Gynecologic Primary Cancer

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000237-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Children;
Pregnant Women

Keywords

Taxol;
Tasigna;
Peritoneal Carcinomatosis Index (PCI);
cytoreductive surgery (CRS);
Unresectable;
SMART System;
necrosis;
Ki-67;
Peritoneal Metastasis;
Progression Free Survival

Recruitment Keyword(s)

None

Condition(s)

Gynecologic Cancer;
Gynecologic Neoplasms;
Peritoneal Carcinomatosis;
Peritoneal Neoplasms;
Ovarian Cancer;
Ovarian Neoplasms;
Colorectal Cancer;
Colorectal Neoplasms;
appendiceal cancer;
appendiceal neoplasms

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: Paclitaxel
Drug: Nilotinib

Supporting Site

National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria.

-Histological confirmation of non-mucinous peritoneal carcinomatosis from colorectal, appendiceal, small bowel, gastric, ovarian, or other gynecologic (i.e., endometrial, fallopian tube, primary peritoneal, cervical) primary by the Laboratory of Pathology, 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 RECIST v1.1. criteria and/or by Peritoneal Carcinomatosis Index (PCI)

-Participants must be assessed to not be candidates for cytoreductive surgery, with PCI score > 30 on screening laparoscopy or with extensive small bowel serosal involvement

-Age >= 18 years

-ECOG performance status <= 2 (Karnofsky >= 60%).

-Participants must have adequate organ and marrow function as defined below:

--Leukocytes >= 3,000/mcL

--Absolute neutrophil count >= 1,000/mcL

--Platelets >= 100,000/mcL

--Total bilirubin within <= 1.5x institutional upper limit of normal (ULN)

--AST (SGOT)/ ALT (SGPT) <= 2.5x institutional ULN

--Serum amylase and lipase <= 1.5x institutional ULN

--Serum potassium and magnesium greater than institutional lower limit of normal

--Creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal calculated using eGFR

-Breastfeeding participant must agree to discontinue breastfeeding.

-Females of child-bearing potential 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 a female suspect she is pregnant while she is participating in this study, she should inform her 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 has received an investigational agent within 30 days prior to the start of study treatment.

-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 within 5 half-lives of the individual agent(s) administered or who have undergone major surgery within the last 12 weeks prior to the start of study treatment.

-Previous intraperitoneal chemotherapy within the last 6 months.

-Participants requiring the use of drugs known to prolong the QT interval or known to strongly inhibit CYP3A4, 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 women are excluded from this study.

-Patients with HIV who have detectable viral load, or whose ART contains QTc Prolonging Medications or CYP3A4 Inhibitors regardless of viral load. (NOTE: Patients 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).

-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 paracentesis procedures in the 30 days prior to initial laparoscopy.

-Advanced hepatic failure, as indicated by Child-Pugh Class C cirrhosis.

-Sensory/motor neuropathy >= Grade 2


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Andrew M. Blakely, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3760B
10 CENTER DR
BETHESDA MD 20892
(240) 760-7647
andrew.blakely@nih.gov

Audra A. Satterwhite, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4W5920
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3552
audra.satterwhite@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT05185947

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