Neoplasms

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Peritoneal Neoplasms

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

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Intestinal Diseases

Rectal Diseases

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Abdominal Neoplasms

Peritoneal Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Paclitaxel

Albumin-Bound Paclitaxel

Nilotinib

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

IP and IV paclitaxel administration with oral nilotinib

Paclitaxel: Intraperitoneal (IP) paclitaxel will be dosed at 60 mg/m2 to be infused over 1 hour on Day 1 of each 3-week cycle; participants with unresectable, but stable or responding disease after C1 through C3 will dose increase IP paclitaxel to 80 mg/m2 for Cycles 4-6. Intravenous (IV) paclitaxel will be infused over 1 hour on Day 2 of the first week of Cycle 1, followed by Day 1 of the subsequent treatment weeks; IV paclitaxel will be dosed at 60 mg/m2 for Week 1 of Cycle 1 and, if tolerated, at 80 mg/m2 for subsequent treatments.

Oral nilotinib will be dosed at 300 mg twice daily. Nilotinib will be administered continually from the loading dose (Day -4) leading up to laparoscopy #2 onward.

Audra A Satterwhite, R.N.

Andrew M Blakely, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

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.

Background:

* Peritoneal carcinomatosis is uniformly fatal if untreated; despite advances in systemic chemotherapy, cytoreductive surgery, and intraperitoneal chemotherapy, survival remains poor for the majority of patients
* The combination of oral nilotinib and intravenous paclitaxel has demonstrated pre-clinical and clinical synergism in the treatment of solid tumors, with an ongoing Phase I trial at the NIH
* The synergy of oral nilotinib with intraperitoneal paclitaxel remains to be characterized
* This study involves the combination of intravenous and intraperitoneal paclitaxel and oral nilotinib for unresectable peritoneal carcinomatosis from colorectal, appendiceal, small bowel, gastric, cholangiocarcinoma, breast, ovarian, or other gynecologic primary histologies

Objective:

-To 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 Index (PCI)

Eligibility:

* Participants \>= 18 years of age with histologically confirmed peritoneal carcinomatosis of colorectal, appendiceal, small bowel, gastric, cholangiocarcinoma, breast, ovarian, or other gynecologic primary histology
* Demonstrated resistance or lack of response to at least one line of already approved and available systemic chemotherapy
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
* No intraperitoneal chemotherapy within the last six months
* Deemed unable to undergo complete cytoreduction

Design:

* Phase II open-label, non-randomized study
* After confirmation of eligibility, at the time of diagnostic laparoscopy, biopsies will be taken, and an intraperitoneal catheter will be placed for subsequent chemotherapy administration
* Up to 6 cycles will be planned, with restaging laparoscopy and biopsies after Cycles 3 and 6

Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer

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

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Rate of downstaging- i.e., the fraction of participants who are successfully downstaged to resectable based on PCI and PI discretion. The fraction of participants who are successfully down-staged to resectable by use of chemotherapy will be reported along with a 95% confidence interval.

Kaplan-Meier method will be used; a 95% confidence interval will be reported on the median overall survival (OS) and overall progression-free survival (PFS).

Peritoneal progression-free survival (pPFS) probability and the percentage of participants who become resectable will be evaluated by individual histologies; median peritoneal progression-free survival (pPFS) will be reported using the Kaplan-Meier method, along with a 95% confidence interval for each histology. The fraction who are able to be down-staged to resectable will be reported for each histology along with a 95% confidence interval.

Safety will be assessed by analyzing the type, grade and frequency of toxicities in addition to laboratory data and vital signs. Adverse events (AEs) will be assessed using CTCAE v.5.0

Outcomes from QOL will be reported using descriptive statistics, as well as comparing the results from before to after treatment: physical and mental health-related quality of life.

Kaplan-Meier method will be used to evaluate peritoneal progression-free survival (pPFS); the median peritoneal progression-free survival (pPFS) will be reported along with a 95% two-sided confidence interval, to be done for all participants.

Response rate by RECIST 1.1 and/or by PCI: the fractions with a clinical response will be reported for all participants along with a 95% confidence interval.

National Cancer Institute (NCI)

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