Cisplatin HAI Study in Patients With Advanced Cancer and Dominant Liver Involvement
The goal of this clinical research study is find the highest safe dose of cisplatin that can be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver.
To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial hepatic (HAI) cisplatin with systemic intravenous liposomal doxorubicin in patients with cancer metastatic to the liver.
To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study Dose Escalation Clinical Study Of Hepatic Intraarterial Cisplatin, In Combination With Systemic Intravenous Liposomal Doxorubicin Administered Every Four Weeks to Patients With Advanced Cancer And Dominant Liver Involvement|
- Maximum tolerated dose (MTD) [ Time Frame: With each 4 week cycle (28 days) ] [ Designated as safety issue: Yes ]Dose level at which no dose limiting toxicities are seen for a monthly cytotoxic regimen combining intraarterial hepatic cisplatin with systemic intravenous liposomal doxorubicin.
|Study Start Date:||March 2005|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Cisplatin + Liposomal Doxorubicin
Cisplatin 100 mg/m^2 Intraarterial and Liposomal Doxorubicin starting dose 20 mg/m^2 by vein on Day 1 every 4 weeks
100 mg/m^2 Intraarterial On Day 1 Every 4 Weeks
Other Names:Drug: Liposomal Doxorubicin
Starting dose 20 mg/m^2 IV On Day 1 Every 4 Weeks
Cisplatin and Liposomal Doxorubicin are chemotherapy drugs designed to fight cancer growth.
If you are eligible to take part in this study, you will enter a treatment period that is divided into cycles. Each cycle is 28 days. You will be hospitalized to receive your chemotherapy. The night of the hospital admission you will receive fluids (normal saline) in your veins to help avoid kidney side effects from the chemotherapy. The morning after your admission to the hospital you will be taken to the interventional radiology suite and a catheter will be placed in your right groin. You must be on bedrest the entire time that the catheter is in place. After the procedure, you will go to Nuclear Medicine and a test called "flow study" will be carried out to confirm the right position of the catheter. After your return to the room, the nurses will start the chemotherapy. You will first receive cisplatin through the groin catheter followed by the liposomal doxorubicin given in one of your veins. The treatment lasts less than three hours and is repeated once every month.
The catheter will be carefully taped so it can not move and to prevent it from coming out. Following completion of chemotherapy infusion, the intra-arterial catheter will be pulled and pressure applied to the groin for 15 minutes. In some cases, the catheter will be removed immediately after your chemotherapy infusions is complete. In some cases, the catheter will remain in longer. You will be on bedrest until the catheter is removed. The catheter will be removed by the physician on call. The catheter will be placed and removed at each treatment.
Blood (about 2 teaspoons) will be drawn for blood counts and liver function tests before each dose to be sure researchers are safely giving you the liposomal doxorubicin.
Since most of the blood flow to your liver comes through the portal vein, your doctors will try to cause an infarct (like a stroke) to the liver artery followed by the injection of cisplatin to kill the tumor cells.
You will be seen by a doctor or advanced practice practitioner every day while you are in the hospital. You will be hospitalized for about 5-7 days until recovery from all immediate treatment related side effects.
You will continue to receive therapy as mentioned above until the disease gets worse or intolerable side effects occur.
At the end of your participation in this study, you will have scans to see if your tumors are growing or shrinking, and blood work (about 3 teaspoons) to make sure your blood counts and the electrolytes (salts in your blood), kidney and liver function are at a safe level.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507962
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Apostolia Tsimberidou, MD, PhD||M.D. Anderson Cancer Center|