Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
Part of paid clinical trials in Greenbrae, California.
- Sponsor
- Jazz Pharmaceuticals
- Study ID
- NCT00361842
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection — DRUGCPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.
Study Details
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.
Key Dates
- Start date
- Jul 31, 2006
- Status verified
- Jul 2021
- Primary completion
- Dec 31, 2008
- Completion
- Dec 31, 2008
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Irinotecan
Primary Outcome Measure
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 [ Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months ]
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| California Cancer Center | Greenbrae | California | 94904 | - |
| Lombardi Comprehensive Cancer Research Institute, Georgetown University Medical Center | Washington D.C. | District of Columbia | 20057 | - |
| NW Oncology & Hematology Associates | Coral Springs | Florida | 33065 | - |
| Broward Oncology Associates | Fort Lauderdale | Florida | 33308 | - |
| St. Joseph's/Candler Health System Inc. | Savannah | Georgia | 31405 | - |
| Presbyterian Hospital | Charlotte | North Carolina | 28204 | - |
| Gabrail Cancer Center | Canton | Ohio | 44718 | - |
| Cancer Care Oklahoma | Oklahoma City | Oklahoma | - | - |
| Cancer Care Oklahoma | Tulsa | Oklahoma | - | - |
| South Carolina Oncology Association | Columbia | South Carolina | 29210 | - |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | - |
Find similar trials in Greenbrae, CA
By condition
By specialty
By research site
California Cancer Center· Greenbrae, CALombardi Comprehensive Cancer Research Institute, Georgetown University Medical Center· Washington D.C., DCNW Oncology & Hematology Associates· Coral Springs, FLBroward Oncology Associates· Fort Lauderdale, FLSt. Joseph's/Candler Health System Inc.· Savannah, GAPresbyterian Hospital· Charlotte, NC
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