Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
Completed · Phase 2
Conditions studied: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer
In brief
This randomized phase II trial is studying giving bevacizumab and cetuximab together with irinotecan to see how well it works compared to giving bevacizumab and cetuximab alone in treating patients with irinotecan-refractory metastatic colorectal cancer. 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 deliver tumor -killing substances to them. Drugs used in chemotherapy, such as irinotecan, also work in different ways to kill tumor cells or stop them from growing. Giving cetuximab and bevacizumab together with irinotecan may improve the ability to block tumor growth.
Key facts
- Study ID
- NCT00077298
- Run by
- National Cancer Institute (NCI)
- People needed
- 70
- Starts
- 2003-12-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2015-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed colorectal cancer
- Metastatic disease by diagnostic imaging studies
- Measurable disease
- At least 1 unidimensionally measurable lesion with minimum lesion size at least twice the slice thickness of the imaging study used
- Refractory to irinotecan, evidenced by clinical documentation
- Received at least 1 prior irinotecan-containing chemotherapy regimen for metastatic disease and progressed during or within 6 weeks after completion of therapy
- Must have received prior irinotecan according to 1 of the following schedules:
- Weekly administration with a starting dose of 100-125 mg/m\^2
- Biweekly administration (every other week) with a starting dose of approximately 180 mg/m\^2
- Once every three weekly administration with a starting dose of 300-350 mg/m\^2
- No known brain metastases
- No prior primary CNS tumors
- Performance status - ECOG 0-1
- Performance status - Karnofsky 80-100%
- More than 3 months
- WBC >= 3,000/mm\^3
- Absolute neutrophil count >= 1,500/mm\^3
- Platelet count >= 100,000/mm\^3
- Hemoglobin >= 9 g/dL
- No bleeding diathesis or coagulopathy
- Bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal (ULN) (5 times ULN in the presence of known liver metastases)
- INR < 1.5 (for patients receiving warfarin)
- Creatinine =< ULN
- Creatinine clearance ≥ 60 mL/min
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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