Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer
Tracking Information | |||||
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First Received Date ICMJE | June 27, 2007 | ||||
Last Updated Date | November 14, 2008 | ||||
Start Date ICMJE | June 2007 | ||||
Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer [ Time Frame: 18-24 months ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00493857 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Assess the incidence of acneiform rash,drug reaction,adverse events, the assessment of progression-free survival,stable disease,time to disease progression, overall survival, objective response rates, safety and trough levels in the serum of patients. [ Time Frame: 18-24 months ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
Assess the incidence of acneiform rash,drug reaction,adverse events, the assessment of progression-free survival,stable disease,time to disease progression, overall survival, objective response rates, safety and trough levels in the serum of patients. [ Time Frame: 18-24 months ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer | ||||
Official Title ICMJE | A Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly Plus Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks Plus Irinotecan (Cohort 2) in Patients With Irinotecan-Refractory Metastatic Colorectal Cancer | ||||
Brief Summary | This study will determine if nimotuzumab provides a benefit in this type of cancer when given in combination with irinotecan. The study will test:
Objectives: Primary: The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer Secondary:
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Detailed Description | The patient will receive nimotuzumab every 2 weeks plus irinotecan. Nimotuzumab will be given at a dose of 400 mg once every 2 weeks for 12 weeks. Irinotecan will be given at the same dose and schedule as the last dose and schedule given during the most recent pre-study irinotecan containing therapy. If the tumour does not show signs of further growth after 12 weeks of treatment, the patient will continue receiving nimotuzumab 400 mg every 2 weeks for up to 18 months or as long as they are getting a benefit from the drug. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | ||||
Intervention ICMJE |
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Study Arm (s) | Experimental: 2
Nimotuzumab 400mg every week or every two weeks
Interventions:
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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 | Terminated | ||||
Estimated Enrollment ICMJE | 100 | ||||
Estimated Completion Date | December 2008 | ||||
Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria
Subject 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 | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493857 | ||||
Other Study ID Numbers ICMJE | YMB 1000-015 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | |||||
Study Sponsor ICMJE | YM BioSciences | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | YM BioSciences | ||||
Verification Date | November 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |