Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583488
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2020-10-05
Brief Title:
Intraperitoneal Docetaxel in Combination With mFOLFOX6 for Gastric Cancer Patients With Peritoneal Carcinomatosis
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
A Phase I Study of Intraperitoneal Docetaxel in Combination With 5-Fluorouracil Leucovorin and Oxaliplatin mFOLFOX6 for Gastric Cancer Patients With Peritoneal Carcinomatosis
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center open-label non-randomized uncontrolled Phase 1 study of intraperitoneal docetaxel in combination with systemic mFOLFOX6 for patients who have gastric cancer with gross peritoneal carcinomatosis GC-PC
Detailed Description:
Gastric cancer GC is one of the leading causes of cancer-related deaths in the United States and has a five-year survival of 40 after surgical resection Metastatic gastric cancer has an even poorer prognosis and most patients die within the first year of diagnosis Most patients are diagnosed in advanced stages of the disease due to non-specific or lack of symptomatology and treatment options are then limited to systemic chemotherapy The peritoneum is the most frequent site of metastasis as well as cancer recurrence Peritoneal Carcinomatosis PC results in adverse clinical sequelae and is ultimately responsible for 60 of all gastric cancer-related deaths While visceral metastases originating from primary gastric cancer are relatively chemosensitive peritoneal carcinomatosis is particularly challenging to treat because of inadequate drug delivery from systemic circulation The primary purpose of this trial is to determine the safety of administering intraperitoneal docetaxel in conjunction with the standard of care treatment regimen of intravenous mFOLFOX6 5-Fluorouracil leucovorin and oxaliplatin in patients with primary gastric cancer with gross peritoneal carcinomatosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None