Spots Global Cancer Trial Database for Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
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Trial Identification
Brief Title: Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
Official Title: Multicenter, Open-Label, Phase 2 Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Carcinoma
Study ID: NCT00361842
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether CPX-1 is effective in patients with advanced colorectal cancer who have already received chemotherapy that included the drug oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90 minutes every two weeks.
Detailed Description: CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine. The two drugs are present inside the liposome in a fixed 1:1 molar ratio. CPX-1 was developed as a means of delivering and preserving a fixed 1:1 molar ratio of the two drugs. This ratio was found in vitro and in vivo models of cancer to have synergistic anti-cancer activity and preservation and delivery of this ratio is important because other ratios of these two drugs have been found to be antagonistic or only additive. Both floxuridine and irinotecan HCl are active chemotherapeutic agents, each approved for clinical use in the United States and Canada for colorectal cancer. Current practice routinely administers 5- fluorouracil with irinotecan in combination regimens in first or second line treatment without the means of preserving the synergistic ratio.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Cancer Center, Greenbrae, California, United States
Lombardi Comprehensive Cancer Research Institute, Georgetown University Medical Center, Washington, District of Columbia, United States
NW Oncology & Hematology Associates, Coral Springs, Florida, United States
Broward Oncology Associates, Fort Lauderdale, Florida, United States
St. Joseph's/Candler Health System Inc., Savannah, Georgia, United States
Presbyterian Hospital, Charlotte, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
Cancer Care Oklahoma, Oklahoma City, Oklahoma, United States
Cancer Care Oklahoma, Tulsa, Oklahoma, United States
South Carolina Oncology Association, Columbia, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada
Contact Details
Name: Gerald Batist, MD
Affiliation: Sir Mortimer B. Davis - Jewish General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: John Marshall, MD
Affiliation: Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Arthur Louie, MD
Affiliation: Jazz Pharmaceuticals
Role: STUDY_DIRECTOR
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