Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity
Start Date
8/19/2025
Completion Date
5/30/2030
Summary
This study is being done to answer the following questions: Can we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most people get for gastric cancer. If you decide to take part in this study, you will first receive a surgical procedure called a diagnostic laparoscopy. This will help the study doctors learn more about your gastric cancer. Laparoscopy is a minimally invasive surgery for which you will be placed under general anesthesia. Then the surgeon will make small incisions (5mm) on your belly through which a camera and thin instruments are introduced to evaluate the abdomen. This procedure takes about 1 hour to complete. Your study group will be assigned during the surgery. The study groups are described further in the 'What are the study groups?' section below. If you are placed into the study group 1, you will not have an intraperitoneal port (a small device which is placed under the skin and fat of your upper abdomen and a tube that is placed into the abdomen). If you are placed into the study group 2, you will have an intraperitoneal port placed. The reason is that in addition to standard chemotherapy, which is given through a vein in your arm, this port will be used to deliver the medication paclitaxel directly inside your abdomen when you are ready to start study treatment. It is important to know that you will not know your study group until after the surgery is over. This is because information that is learned during the surgery will help determine which study group you are put in. Once you have fully healed from this surgery, you will start study treatment. Depending on which study group you are assigned, you will either receive a standard chemotherapy regimen (the regimen will be chosen by you and your doctor) if you are in study group 1, or paclitaxel through a tube in your belly plus chemotherapy given through a vein in your arm if you are in study group 2. All participants will get treatment for three (3) months after which you will undergo reevaluation. If the disease is under control or responding to treatment, you may continue the assigned treatment until your disease gets worse, the side effects become too severe, or you may be offered a surgical procedure to remove the cancer if the amount of disease is low and can be completely removed as determined by a surgeon. There is a very small chance that during the laparoscopy surgical procedure, the doctor might find something called "intra-abdominal adhesions". These are areas where the stomach has healed previously and created scar tissue. If this scar tissue prevents the surgeon from being able to place a port in the correct area, you would be ineligible to receive the study treatment. If this happens, you may still receive standard of care therapy after your surgery, but you will not be able to continue on the study. If you have more questions about this, you can ask your surgeon or the study team to help. After you finish your study treatment, your doctor or study team will watch you for side effects. They will continue to follow your condition every three (3) months during the first two (2) years, then every six (6) months until year 5. You may be reevaluated with Chest/Abdomen/Pelvis scans every three-six (3-6) months for up to five (5) years if decided by your doctor.
Detailed Description
PRIMARY OBJECTIVES: I. In the phase II portion, to determine the progression free survival (PFS) from randomization. II. In the phase III portion, to determine overall survival (OS) from randomization. SECONDARY OBJECTIVE: I. To compare the safety and tolerability of the intraperitoneal chemotherapy + systemic therapy regimen vs the systemic therapy alone regimen. OUTLINE: STEP 0: Patients undergo diagnostic laparoscopy within 4 weeks of study registration. STEP 1: Patients are randomized to 1 of 2 arms at the time of Step 0 diagnostic laparoscopy. ARM A: Patients receive standard of care systemic therapy per physician's choice. Patients with stable disease or a response after 12 weeks may continue to receive standard of care treatment in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study and may undergo additional diagnostic laparoscopies as clinically indicated. ARM B: Patients undergo placement of an intraperitoneal port. Patients receive leucovorin calcium intravenously (IV) over 15-30 minutes, fluorouracil IV push, paclitaxel IV over 1-2 hours and paclitaxel intraperitoneally (IP) on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease or a response after 12 weeks may continue to receive treatment in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and CT and/or MRI throughout the study and may undergo additional diagnostic laparoscopies as clinically indicated. After completion of study treatment, patients are followed up every 3 months for 2 years then every 6 months for up to 5 years after Step 1 randomization.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Standard of Care Chemotherapy
Biospecimen Collection
Computed Tomography
Diagnostic Laparoscopy
Intraperitoneal Port Placement
Magnetic Resonance Imaging
Intraperitoneal Paclitaxel
Conditions
Locations
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
United States
Yale University
New Haven, Connecticut 06520
United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois 60523
United States
Memorial Hospital East
Shiloh, Illinois 62269
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
United States
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Siteman Cancer Center-South County
St Louis, Missouri 63129
United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United States
Memorial Sloan Kettering Commack
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester
East White Plains, New York 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin 53151
United States
Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
United States
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United States