Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
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Tracking Information | |||||||||||||
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First Received Date ICMJE | August 7, 2006 | ||||||||||||
Last Updated Date | May 16, 2012 | ||||||||||||
Start Date ICMJE | July 2006 | ||||||||||||
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Response rate will be assessed using RECIST criteria. [ Time Frame: Q2months ] [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures ICMJE |
Response rate will be assessed using RECIST criteria. | ||||||||||||
Change History | Complete list of historical versions of study NCT00361842 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
Incidence and severity of adverse experiences and changes in laboratory values [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ] | ||||||||||||
Original Secondary Outcome Measures ICMJE |
Incidence and severity of adverse experiences and changes in laboratory values | ||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer | ||||||||||||
Official Title ICMJE | Multicenter, Open-Label, Phase 2 Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Carcinoma | ||||||||||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Phase 2 | ||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Neoplasms | ||||||||||||
Intervention ICMJE | Drug: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine. |
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Study Arm (s) | |||||||||||||
Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Enrollment ICMJE | 59 | ||||||||||||
Completion Date | December 2008 | ||||||||||||
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Location Countries ICMJE | United States, Canada | ||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00361842 | ||||||||||||
Other Study ID Numbers ICMJE | Protocol CLTR0105-201 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
Responsible Party | Celator Pharmaceuticals | ||||||||||||
Study Sponsor ICMJE | Celator Pharmaceuticals | ||||||||||||
Collaborators ICMJE | |||||||||||||
Investigators ICMJE |
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Information Provided By | Celator Pharmaceuticals | ||||||||||||
Verification Date | May 2012 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |