Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab and Erlotinib
Status:
Unknown status
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
This is a clinical trial investigating the effectiveness and safety of the combination of the
study drugs cetuximab and erlotinib in patients with advanced (metastatic) refractory
colorectal (bowel) cancer. If bowel cancer has spread to other organs (metastatic colorectal
cancer), it is usually incurable and life-expectancy without treatment is less then 6 months
on average. Currently, chemotherapy has been shown to have a significant impact in advanced
colorectal cancer in terms of maintenance of quality of life and extension of survival.
However, ultimately tumours will develop resistance to chemotherapy. Treatment options and
subsequent survival at that stage are very limited. Therefore, new therapeutic approaches are
urgently needed.
It is common for colorectal cancer cells to contain growth receptors, like antennae, on their
surface which regulate their growth. The drugs used in this trial have been shown to be
effective in targeting one of these growth receptors; the epidermal growth factor receptor
(EGFR). Cetuximab is an antibody (protein produced by the immune system involved in the
defense of the body against infections) against EGFR. Cetuximab has been shown to improve the
survival of patients with chemotherapy refractory advanced colorectal cancer. Erlotinib is a
protein that prevents activation and hence signaling by EGFR. Erlotinib improves survival in
patients with advanced lung cancer. Although, each of these drugs are known to be effective
at inhibiting EGFR when they are given alone, at least in some cases, it is hoped that using
two drugs that target the same receptor pathway in different ways will provide a more
effective treatment.
50 patients from four hospitals in Australia will participate in this trial, with
approximately 25 patients being enrolled at Austin Health. All participants will receive the
same treatment.
Neither of the study drugs are chemotherapy, and hence it is expected that the treatment
would be well tolerated. The most frequent side effect associated with EGFR inhibitors is
skin rash. Other possible side effects are diarrhea and low magnesium levels.
Phase:
Phase 2
Details
Lead Sponsor:
Austin Health
Collaborators:
Ballarat Health Services Queen Elizabeth Hospital, Adelaide Royal North Shore Hospital