Overview

Phase II Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Ovarian, Colorectal, or Appendiceal Cancer

Status:
Not yet recruiting

Trial end date:
2031-12-30

Target enrollment:

Participant gender:

Summary

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 ovarian, colorectal, or appendiceal 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 non-mucinous peritoneal carcinomatosis of ovarian, colorectal, or appendiceal 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

Phase:

Phase 2

Details

Lead Sponsor:

National Cancer Institute (NCI)

Treatments:

Paclitaxel