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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD)
Dose level at which no dose limiting toxicities are seen for a monthly cytotoxic regimen combining intraarterial hepatic cisplatin with systemic intravenous liposomal doxorubicin.
With each 4 week cycle (28 days)
Apostolia Tsimberidou, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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