Status:
COMPLETED
Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Phase II trial to demonstrate the response rate, using the Response evaluation criteria in solid tumours (RECIST) criteria, of patients with locally advanced / metastatic colorectal cancer treated w...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the colon or rectum.
- Patients must not have a mutation of K-ras
- Inoperable metastatic or locoregional disease (synchronous or recurrence)
- No previous chemotherapy for established metastatic disease (adjuvant chemotherapy must have been completed more than 6 months prior to trial entry)
- Measurable or evaluable disease
- Bone marrow function: neutrophil count \>1.5 x109/l and platelet count \>150 x109/l
- Hepatobiliary function: serum bilirubin \<1.5 x upper limit of normal (ULN); ALP \<5 x ULN; transaminase (AST or ALT) \<3 x ULN.(≤ 5 if liver mets are present)
- Renal function: estimated creatinine clearance \>50 ml/min, or measured Glomerular filtration rate (GFR) (EDTA or creatinine clearance) in normal range
- ECOG performance status 0-1 and considered fit and able to undergo all possible treatments
- For women of child-bearing potential a negative pregnancy test is required and adequate contraceptive precautions such as a sheath for their partner must be used
- For men - adequate contraception such as a sheath must be used
- Patients must give written, informed consent
- Life expectancy ≥ 3 months.
Exclusion
- Patients that have a K-ras mutation
- Concurrent uncontrolled medical illness, or other previous or current malignant disease likely to interfere with protocol treatments or comparisons
- Partial or complete bowel obstruction
- Prior EGFR antibody therapy
- Age \<18
- Chronic diarrhoea or inflammatory bowel disease
- Known Pyruvate Dehydrogenase Phosphatase (DPD) deficiency
- Gilbert's syndrome or other congenital abnormality of biliary transport
- Previous transplant surgery, requiring immunosuppressive therapy
- Regular / uncontrolled angina or cardiac arrhythmias
- Clinically relevant coronary artery disease. History of Myocardial infarction in the last 12 months
- Previous investigational agent in the last 4 weeks
- Metastatic disease to brain
- Any pregnant or lactating women
- Patients receiving therapy with haloginated antiviral drugs (eg: sorivudine)
- Patients who have experienced life-threatening toxicities with fluoropyrimidines treatment
- Patients suffering from any condition that may affect the absorption of UFT or folinic acid.
- Patients with known deficiency of or are on inhibitors of cytochrome P450 2A6
- Patients who have previously had radiotherapy to the abdomen or pelvis in the last 6 months
- Any medical or psychological condition that in the opinion of the investigator would not enable the patient to complete the study or knowingly give informed consent
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01225744
Start Date
April 1 2009
End Date
May 1 2013
Last Update
June 11 2014
Active Locations (3)
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1
North Wales Cancer Treatment Centre
Llansantffraid Glan Conwy, United Kingdom, LL18 5UJ
2
The Royal Marsden
London and Surrey, United Kingdom
3
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX