Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer

Phase 1/2 Completed 32 enrolled Massachusetts General Hospital Beth Israel Deaconess Medical Center · collab Dana-Farber Cancer Institute · collab Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and erlotinib when administered in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating(Phase II portion) patients with locally advanced rectal cancer.

Timeline

Start: 2006-05
Primary completion: 2010-04
Completion: 2011-07

Publications

Blaszkowsky LS, Ryan DP, Szymonifka J, Borger DR, Zhu AX, Clark JW, Kwak EL, Mamon HJ, Allen JN, Vasudev E, Shellito PC, Cusack JC, Berger DL, Hong TS. Phase I/II study of neoadjuvant bevacizumab, erlotinib and 5-fluorouracil with concurrent external beam radiation therapy in locally advanced rectal cancer. Ann Oncol. 2014 Jan;25(1):121-6. doi: 10.1093/annonc/mdt516.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Erlotinib	Small molecule	50 mg	Oral
Subject	Erlotinib	Small molecule	100 mg	Oral
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	fluorouracil	Small molecule	225 mg/m2	—

Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer

Summary

Timeline

Publications

Drugs

Indications