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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

October 13, 2022

Primary Completion Date

January 27, 2025

Study Completion Date

April 4, 2025

Conditions
Gynecologic CancerGynecologic NeoplasmsPeritoneal CarcinomatosisPeritoneal NeoplasmsOvarian CancerOvarian NeoplasmsColorectal CancerColorectal NeoplasmsAppendiceal CancerAppendiceal Neoplasms
Interventions
DRUG

Paclitaxel

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.

DRUG

Nilotinib

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.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH