Bevacizumab, Fluorouracil, Leucovorin Calcium, and Oxaliplatin Before Surgery in Treating Patients With Stage II-III Rectal Cancer

Summary

This phase II trial studies how well bevacizumab, fluorouracil, leucovorin calcium, and oxaliplatin before surgery works in treating patients with stage II-III rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with fluorouracil, leucovorin calcium, and oxaliplatin may be an effective treatment for rectal cancer.

Timeline

Start

2013-08-02

Primary completion

2018-03-14

Completion

2020-06-24

Outcome

Missed primary endpoint

Stopped (Enrollment): “Insufficient Accrual”

paper Neoadjuvant bevacizumab with modified FOLFOX7 without radiation failed to meet the goal of pathological complete response rate PMID 32649004 ↗

paper The study failed to meet the required three pCRs in the first 18 pts. PMID 32649004 ↗

Publications

• Barzi A, Choi A, Tsao-Wei D, Iqbal S, El-Khoueiry A, Agafitei DR, Cologne KG, Lenz HJ. Phase II Trial of Neoadjuvant Bevacizumab with Modified FOLFOX7 in Patients with Stage II and III Rectal Cancer. Oncologist. 2020 Dec;25(12):e1879-e1885. doi: 10.1634/theoncologist.2020-0642. Epub 2020 Aug 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Leucovorin	Small molecule	20 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Indications