Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507962
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2007-07-25
Brief Title:
Cisplatin HAI Study in Patients With Advanced Cancer and Dominant Liver Involvement
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PRIMARY Objectives
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
SECONDARY Objectives
To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin
PRIMARY Objectives
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
SECONDARY Objectives
To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None