Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab and Erlotinib (Dux)
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|ClinicalTrials.gov Identifier: NCT00784667|
Recruitment Status : Unknown
Verified November 2008 by Austin Health.
Recruitment status was: Active, not recruiting
First Posted : November 4, 2008
Last Update Posted : November 30, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Cetuximab Drug: Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab (Erbitux) and Erlotinib (Tarceva) in Patients With Chemotherapy-refractory Colorectal Cancer|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||January 2010|
|Estimated Study Completion Date :||February 2011|
- To determine the response rate (RECIST criteria). Responses will be evaluated for the whole patient group and separately for k-ras wild-type and k-ras mutant tumours [ Time Frame: 6 weekly ]
- Toxicity [ Time Frame: Weekly ]
- Progression free survival [ Time Frame: 6 weekly ]
- Overall survival [ Time Frame: Weekly ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784667
|Australia, New South Wales|
|Royal North Shore Hospital|
|Sydney, New South Wales, Australia|
|Australia, South Australia|
|Queen Elizabeth Hospital|
|Adelaide, South Australia, Australia|
|Ballarat Base Hospital|
|Ballarat, Victoria, Australia|
|Melbourne, Victoria, Australia, 3084|