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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00577109 |
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Date of registration:
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18/12/2007 |
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Primary sponsor: |
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Public title:
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A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.
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Scientific title:
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An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-Free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer. |
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Date of first enrolment:
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October 2001 |
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Target sample size:
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37 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00577109 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult patients, >=18 years of age;
- colorectal cancer;
- advanced or recurrent disease;
- >=1 measurable lesion;
- >=6 months since prior adjuvant therapy, and >=4 weeks since prior radiotherapy.
Exclusion Criteria:
- previous treatment for colorectal cancer;
- significant history of cardiac disease in past 6 months;
- other invasive malignancy within past 5 years, except for nonmelanoma skin cancer,
and successfully treated cervical or prostate cancer.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Drug: 5 FU
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Drug: bevacizumab [Avastin]
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Drug: Cetuximab
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Drug: Irinotecan
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Drug: Leucovorin
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Primary Outcome(s)
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Progression-free survival
[Time Frame: 12 months]
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Secondary Outcome(s)
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AEs, laboratory parameters.
[Time Frame: Throughout study]
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Objective response rate, rate of resection of hepatic metastases, overall survival.
[Time Frame: Event driven]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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