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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00784667
Registration number
NCT00784667
Ethics application status
Date submitted
3/11/2008
Date registered
4/11/2008
Date last updated
30/11/2010
Titles & IDs
Public title
Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab and Erlotinib
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Scientific title
Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab (Erbitux) and Erlotinib (Tarceva) in Patients With Chemotherapy-refractory Colorectal Cancer
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Secondary ID [1]
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H2008/03282
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Universal Trial Number (UTN)
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Trial acronym
Dux
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Drugs - Erlotinib
Treatment: Drugs: Cetuximab
400mg/m2 intravenously week 1, then 250 mg/m2 weekly intravenously
Treatment: Drugs: Erlotinib
100mg orally daily continuously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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6 weekly
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Secondary outcome [1]
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Toxicity
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Assessment method [1]
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Timepoint [1]
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Weekly
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Secondary outcome [2]
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Progression free survival
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Assessment method [2]
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Timepoint [2]
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6 weekly
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Secondary outcome [3]
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Overall survival
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Assessment method [3]
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Timepoint [3]
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Weekly
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Eligibility
Key inclusion criteria
- Age>18 years
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent or to complete the protocol
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2011
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Royal North Shore Hospital - Sydney
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Recruitment hospital [2]
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Queen Elizabeth Hospital - Adelaide
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Recruitment hospital [3]
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Ballarat Base Hospital - Ballarat
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Recruitment hospital [4]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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- Adelaide
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Recruitment postcode(s) [3]
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- Ballarat
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Recruitment postcode(s) [4]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Austin Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Ballarat Health Services
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Queen Elizabeth Hospital, Adelaide
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Royal North Shore Hospital
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Address [3]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00784667
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00784667
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