Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab and Erlotinib
NCT ID: NCT00784667
Last Updated: 2010-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2008-10-31
2011-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Cetuximab
400mg/m2 intravenously week 1, then 250 mg/m2 weekly intravenously
Erlotinib
100mg orally daily continuously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological diagnosis of colorectal cancer
* Metastatic disease not amenable to resection
* Measurable disease as assessed by CT scan using RECIST criteria
* Received and failed fluoropyrimidine therapy, where failure is defined as radiological progression after therapy for metastatic disease, prior adjuvant therapy, or toxicity limiting further therapy
* Received and failed oxaliplatin therapy, where failure is defined as radiological progression after therapy for metastatic disease, prior adjuvant therapy ,or toxicity (including neuro-toxicity) limiting further therapy
* Received and failed irinotecan therapy, where failure is defined as radiological progression after therapy for metastatic disease or toxicity limiting further therapy
* ECOG PS 0-1
* Adequate bone marrow function with platelets \> 100 X 109/l; neutrophils \> 1.5 X 109/l
* Adequate renal function, with calculated creatinine clearance \>40 ml/min (Cockcroft and Gault).
* Adequate hepatic function with serum total bilirubin \< 1.25 X upper limit of normal range and ALT or AST\<2.5xULN (\<5xULN if liver metastases present)
* Life expectancy of at least 12 weeks
* No other concurrent uncontrolled medical conditions
* No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent \>2 years previously without evidence of relapse
* Women and partners of women of childbearing potential must agree to use adequate contraception
* Written informed consent including consent for biomarker studies
Exclusion Criteria
* Prior treatment with drugs targeting EGFR such as cetuximab, panitumumab or erlotinib
* Participation in any investigational drug study within the previous 4 weeks
* Patients with uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris
* Untreated CNS metastases
* Pregnancy or lactation
* k-ras mutant tumours now excluded
18 Years
ALL
No
Sponsors
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Ballarat Health Services
OTHER
Queen Elizabeth Hospital, Adelaide
UNKNOWN
Royal North Shore Hospital
OTHER
Austin Health
OTHER_GOV
Responsible Party
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Austin Health
Locations
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Royal North Shore Hospital
Sydney, New South Wales, Australia
Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Ballarat Base Hospital
Ballarat, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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H2008/03282
Identifier Type: -
Identifier Source: org_study_id