View Clinical Trial (Medical Research Study)
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer. - NCT00700102-68114(Clinical Trial 691187)
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Omaha |
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State:
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NE |
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68114 |
| Conditions: |
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Colorectal Cancer |
| Purpose: |
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This study will evaluate the efficacy and safety of adding Avastin to crossover
fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have
experienced disease progression under first line treatment with standard chemotherapy plus
Avastin. Patients will be randomized to one of 2 chemotherapy strata. Those in stratum 1
will receive chemotherapy (AIO-IRI, FOLFIRI, CAPIRI or XELIRI) alone, or in combination with
Avastin (5mg/kg iv on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of
each 6 week cycle) and those in stratum 2 will receive chemotherapy (FUFOX, FOLFOX, CAPOX or
XELOX) alone, or in combination with Avastin (5mg/kg on days 1 and 14 of each 4 week cycle
or 7.5mg/kg on days 1 and 22 of each 6 week cycle). The anticipated time on study treatment
is until disease progression, and the target sample size is 500+ individuals.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- adult patients, >=18 years of age;
- metastatic colorectal cancer and disease progression, previously treated with
first-line chemotherapy plus Avastin;
- ECOG <=2.
Exclusion Criteria:
- first line patients with progression-free survival in first line of <4 months;
- other malignancies, except for curatively treated basal and squamous cell cancer of
the skin or in situ cancer of the cervix;
- clinically significant cardiovascular disease within 1 year of randomization;
- CNS metastases. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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October 7, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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