Status:
UNKNOWN
Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab and Erlotinib
Lead Sponsor:
Austin Health
Collaborating Sponsors:
Ballarat Health Services
Queen Elizabeth Hospital, Adelaide
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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) c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00784667
Start Date
October 1 2008
End Date
February 1 2011
Last Update
November 30 2010
Active Locations (4)
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1
Royal North Shore Hospital
Sydney, New South Wales, Australia
2
Queen Elizabeth Hospital
Adelaide, South Australia, Australia
3
Ballarat Base Hospital
Ballarat, Victoria, Australia
4
Austin Health
Melbourne, Victoria, Australia, 3084