EUCTR2010-021037-32-DE
Active, not recruiting
Phase 1
A study for people with advanced colorectal cancer who have been treated with a specific chemotherapy regimen (Bevacizumab, Oxaliplatin, and a Fluoropyrimidine) which was ineffective in stopping the spread of the colorectal cancer. Study participants will receive a different chemotherapyregimen (Irinotecan, Folinic Acid, and 5-Fluorouracil) and be randomly andunknowingly assigned to also receive the study drug (ramucirimab) or a non-active compound (placebo)
Eli Lilly and Company Limited, Indianapolis0 sites1,050 target enrollmentDecember 6, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Eli Lilly and Company Limited, Indianapolis
- Enrollment
- 1050
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically or cytologically confirmed metastatic colorectal cancer excluding primary tumors of appendiceal origin (patients are eligible to enroll irrespective of KRAS mutation status)
- •\- Confirmed metastatic colorectal cancer (Stage IV)
- •\- The patient has received first\-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and a)Experienced radiographic disease progression during first\-line therapy, or b)Experienced radiographic disease progression within 6 months after the last dose of first\-line therapy, or c)Discontinued part or all of first\-line therapy due to toxicity and experienced radiographic disease progression within 6 months after the last dose of first\-line therapy; Note that a patient must have received a minimum of 2 doses of bevacizumab as part of a first\-line regimen containing chemotherapy. In addition, a patient must have received at least 1 cycle of first\-line therapy that included bevacizumab, oxaliplatin, and a fluoropyrimidine inthe same cycle. Note that a patient must not have received more than 2 different fluoropyrimidines as part of a first\-line regimen; disease progression is not an acceptable reason for discontinuing one fluoropyrimidine and starting a second fluoropyrimidine.
- •\- Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted). Note that re\-challenge with oxaliplatin is permitted and will be considered part of 1 first\-line regimen for metastatic disease.
- •\- Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1\.1 (RECIST v. 1\.1\)
- •\- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •\- Adequate hematologic, renal, hepatic and coagulation function
- •\- Consent to provide a historical colorectal cancer tissue sample for assessment of biomarkers and the tumor tissue sample is available
- •\- Ability to provide signed informed consent
- •Are the trial subjects under 18? no
Exclusion Criteria
- •\- Receipt of bevacizumab within 28 days prior to randomization
- •\- Receipt of any investigational therapy within 28 days prior to randomization
- •\- Receipt of any previous systemic therapy, other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine, for first\-line treatment of metastatic colorectal cancer
- •\- Known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression
- •\- Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 12 months prior to randomization
- •\- Pregnant (confirmed by serum beta human chorionic gonadotropin \[ß HCG] test within 7 days prior to randomization) or lactating
- •\- History of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) in the 12 months prior to randomization
- •\- Acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator
- •\- Grade 3 or higher bleeding event within 3 months prior to randomization
- •\- Experience of any of the following during first\-line therapy with a bevacizumab\-containing regimen: an arterial thrombotic/thromboembolic event, Grade 4 hypertension, Grade 3 proteinuria, a Grade 3\-4 bleeding event, or bowel perforation
Outcomes
Primary Outcomes
Not specified
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