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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2015-02
NCT00265850Uploaded 02-12-2020
Access via NCI by Request
PDS UID: nci-data-403
A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum
Provider Information
Provider Data DescriptionDataset NCT00265850-D6-Dataset.csv (table2) is one of 8 datasets associated with PubMed ID 28632865. This dataset contains information that will allow you to reproduce table 2 of the manuscript.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryPURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer. RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.
ConditionsColorectal Cancer
Intervention TypeBiological: bevacizumab
Biological: cetuximab
Drug: FOLFOX or
Drug: FOLFIRI
Drug(s)Drug: FOLFOX or
Drug: FOLFIRI
Total Enrolled2334
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm A: FOLFOX or FOLFIRI + bevacizumab - Active Comparator
Arm B: FOLFOX or FOLFIRI + cetuximab - Experimental
Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab - Experimental
Secondary IDU10CA037447
PubMed (PMID)17553204
16356309
31548349
31408415
31042420
28632865
Collaborator(s)National Cancer Institute (NCI)
SWOG Cancer Research Network
Bristol-Myers Squibb
Aptuit
Region(s)United States
Canada
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00265850-D6
Data DictionaryNCT00265850-D6-Data-Dictionary.pdf
DATANCT00265850-D6-Dataset.csv
OTHERREADME.pdf
Files: NCT00265850-D5
Data DictionaryNCT00265850-D5-Data-Dictionary.pdf
DATANCT00265850-D5-Dataset.csv
OTHERREADME.pdf
Files: NCT00265850-D4
Data DictionaryNCT00265850-D4-Data-Dictionary.pdf
DATANCT00265850-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT00265850-D3
Data DictionaryNCT00265850-D3-Data-Dictionary.pdf
DATANCT00265850-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00265850-D2
Data DictionaryNCT00265850-D2-Data-Dictionary.pdf
DATANCT00265850-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00265850-D1
Data DictionaryNCT00265850-D1-Data-Dictionary.pdf
DATANCT00265850-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT00265850-D7
Data DictionaryNCT00265850-D7-Data-Dictionary.pdf
DATANCT00265850-D7-Dataset.csv
OTHERREADME.pdf
Files: NCT00265850-D8
Data DictionaryNCT00265850-D8-Data-Dictionary.pdf
DATANCT00265850-D8-Dataset.csv
OTHERREADME.pdf
Files: NCT00265850-D14
Data DictionaryNCT00265850-D14-Data-Dictionary_2.pdf
DATANCT00265850-D14-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00265850-D15
Data DictionaryNCT00265850-D15-Data-Dictionary_2.pdf
DATANCT00265850-D15-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00265850-D9
Data DictionaryNCT00265850-D9-Data-Dictionary_2.pdf
DATANCT00265850-D9-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00265850-D10
Data DictionaryNCT00265850-D10-Data-Dictionary_2.pdf
DATANCT00265850-D10-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00265850-D11
Data DictionaryNCT00265850-D11-Data-Dictionary_2.pdf
DATANCT00265850-D11-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00265850-D12
Data DictionaryNCT00265850-D12-Data-Dictionary_2.pdf
DATANCT00265850-D12-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00265850-D13
Data DictionaryNCT00265850-D13-Data-Dictionary_2.pdf
DATANCT00265850-D13-Dataset_2.csv
OTHERREADME.pdf
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