Clinical Trials Logo
  1. Home
  2. Peritoneal Carcinomatosis
  3. NCT04583488

Intraperitoneal Docetaxel in Combination With mFOLFOX6 for Gastric Cancer Patients With Peritoneal Carcinomatosis

Peritoneal Carcinomatosis Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04583488
Study type Interventional
Source Johns Hopkins University
Contact Fabian M Johnston, MD, MHS
Phone 410-502-0197
Email fjohnst4@jhmi.edu
Status Recruiting
Phase Phase 1
Start date November 1, 2020
Completion date December 31, 2026
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04826432 - Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis Phase 2
Recruiting NCT03127774 - Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma Phase 2
Recruiting NCT04024917 - Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis N/A
Active, not recruiting NCT03508570 - Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis Phase 1
Not yet recruiting NCT04352894 - Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection N/A
Completed NCT06318793 - Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis
Terminated NCT01683864 - Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer Phase 2/Phase 3
Completed NCT05547568 - A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring?
Recruiting NCT04547725 - Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis N/A
Completed NCT03304210 - PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer Phase 1
Withdrawn NCT03682744 - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC) Phase 1
Terminated NCT04047771 - A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis Phase 1
Recruiting NCT05623787 - Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms N/A
Recruiting NCT05063019 - Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index N/A
Completed NCT02891447 - Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer Phase 2
Recruiting NCT04231175 - Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer N/A
Not yet recruiting NCT04734691 - Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study Phase 2
Recruiting NCT04108936 - Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
Completed NCT02604784 - Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors Phase 1/Phase 2
Completed NCT01764789 - Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer N/A