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

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)

FacilityCityStateZIPSite coordinators
California Cancer CenterGreenbraeCalifornia94904-
Lombardi Comprehensive Cancer Research Institute, Georgetown University Medical CenterWashington D.C.District of Columbia20057-
NW Oncology & Hematology AssociatesCoral SpringsFlorida33065-
Broward Oncology AssociatesFort LauderdaleFlorida33308-
St. Joseph's/Candler Health System Inc.SavannahGeorgia31405-
Presbyterian HospitalCharlotteNorth Carolina28204-
Gabrail Cancer CenterCantonOhio44718-
Cancer Care OklahomaOklahoma CityOklahoma--
Cancer Care OklahomaTulsaOklahoma--
South Carolina Oncology AssociationColumbiaSouth Carolina29210-
Sarah Cannon Research InstituteNashvilleTennessee37203-

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