Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma

Colorectal Cancer Clinical Trial

Official title: A Phase I Trial With Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerated dose of heated intra-abdominal oxaliplatin that can be given to patients with colon cancer. Researchers also want to learn more about the ways that pediatric and young adult colon cancer may be different from colon cancer in adults.

Clinical Trial Description

Surgery and Study Drug Administration:

If you are found to be eligible to take part in this study, abdominal surgery will be performed to try to remove as many tumors as possible. The abdominal surgery is not being performed specifically for this research study and would be performed even if you did not take part in this study. You will be given a separate consent form to sign that explains the details and risks of surgery in more detail.

During surgery, the abdomen will be temporarily closed. Then the abdominal wash will begin. During the "abdominal wash," heated oxaliplatin will be delivered through plastic tubing that is connected to a pump into the abdomen. The pump pushes the heated oxaliplatin into the abdomen and then pulls it out and recirculates the oxaliplatin. The skin of the abdomen is temporarily closed during the abdominal wash. The surgeon will also "wash" over the closed area of the surgical site. A pump will be used to pump heated oxaliplatin in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdominal wall so the oxaliplatin reaches all areas in the abdomen. After 90 minutes, the oxaliplatin is removed and the abdomen will be "washed" with saline and all fluid will be removed before the surgeon permanently closes the abdomen with 3 layers of stitches.

Two (2) pea-sized tissue samples (tumor and normal abdominal tissue), 2 tablespoons of blood will be sent to the laboratory of Dr. Scott Kopetz for tissue evaluation and extraction of RNA (genetic material). One (1) tumor sample will be removed before the procedure and the other sample will be removed at the end of the procedure. The samples will be examined under a microscope and DNA (the genetic material in cells) will be removed to look for any changes to the DNA. The results of these tests will not be shared with you, nor will they be used for any decisions regarding your treatment.

There is a chance that the surgeon may decide during the surgery that the abdominal wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, your doctor will discuss other treatment options with you.

Study Visits:

On Day 1 after surgery:

• Blood (about 1 teaspoon) will be drawn for routine tests.

• You will have a physical exam.

On Days 2-5, 11, 14, and 30 after surgery:

• Blood (about 1-3 teaspoons) will be drawn for routine tests.

• You will have a physical exam.

• On Day 30 only, you will have a hearing test.

If the doctor thinks it is needed, you will also have follow up visits at 3 and 6 months after surgery. If these visits occur here at MD Anderson, you will not have a hearing test, but you will have an MRI, CT, or PET-CT scan to check the status of the disease. The 3 and 6 month visits following surgery may be performed at your local doctor's office and/or laboratory.

Length of Study:

You will remain on study for up to 6 months. You will be taken off study if the disease gets worse.

If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, you may be eligible for a re-perfusion, which is a repeat of the surgery and study drug administration. If you are eligible for a re-perfusion, your participation on this study will end and you will be given a new consent form to sign in order to be re-enrolled back onto this study.

This is an investigational study. Oxaliplatin is FDA approved and commercially available for the treatment of advanced bladder cancer, metastatic testicular cancer, metastatic ovarian cancer, hepatoblastoma, neuroblastoma, metastatic appendiceal cancer, and abdominal mesothelioma. The use of heated oxaliplatin given intra-abdominally in pediatric patients with colon cancer is investigational. The study doctor can explain how the study drug is designed to work.

Up to 30 participants will be enrolled in this study. All will take part at MD Anderson. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Fever

• NCT number: NCT02062749
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: May 19, 2014
• Completion date: June 27, 2018