Multicenter, Open-Label, Phase 2 Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Carcinoma
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate will be assessed using RECIST criteria.
Q2months
No
Gerald Batist, MD
Principal Investigator
Sir Mortimer B. Davis - Jewish General Hospital
United States: Food and Drug Administration
Protocol CLTR0105-201
NCT00361842
July 2006
December 2008
Name | Location |
---|---|
California Cancer Center | Fresno, California 93720 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Broward Oncology Associates | Ft. Lauderdale, Florida 33308 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Lombardi Comprehensive Cancer Research Institute, Georgetown University Medical Center | Washington DC, District of Columbia 20057 |
NW Oncology & Hematology Associates | Coral Springs, Florida 33065 |
St. Joseph's/Candler Health System Inc. | Savannah, Georgia 31405 |
Cancer Care Oklahoma | Oklahoma City, Oklahoma |
South Carolina Oncology Association | Columbia, South Carolina 29210 |