A Randomized Phase II Study of Irinotecan and Cetuximab with or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy

Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, 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 and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer.
March 05, 2015
Colorectal Cancer
Amaryllis Gil, MD

Elmhurst Hospital

This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.

View more information about E7208 at ClinicalTrials.gov

  • Histologically confirmed adenocarcinoma of the colon or rectum, including advanced disease or histologic variants of adenocarcinoma
  • K-ras wild type
  • Must have received prior first-line therapy comprising oxaliplatin-based fluoropyrimidine-containing chemotherapy and bevacizumab for metastatic colorectal cancer
  • No more than 42 days since confirmed disease progression 
  • No brain or central nervous system metastases
  • No other cancer requiring therapy within the past 3 years except in situ carcinoma or nonmelanoma skin cancer
  • No history of inflammatory bowel disease requiring intervention within the past 12 months
  • No prior therapy with drugs other than oxaliplatin and a fluoropyrimidine plus bevacizumab for colorectal cancer
  • Women must not be pregnant or breast-feeding
  • No chronic inflammatory bowel disease and/or bowel obstruction
Accepting Participants
Kathy Seymour, BSN
(331) 221-2168