Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arbeitsgemeinschaft medikamentoese Tumortherapie
With
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Untreated advanced metastatic colorectal cancer patients
Adequate tissue to evaluate for genotyping (10 x 10µm thick formalin fixed paraffin embedded tissue sections and one corresponding HE stained slide or a FFPE tumor block)
Patients must fulfill all criteria listed below prior to enrolment in the study:
Untreated wild-type KRAS metastatic colorectal cancer
Previous adjuvant therapy must have been completed \> 6 months before therapy initiation on this study
Age \>18 years
Measureable disease with CT or MRI
ECOG performance status of 0-2
Adequate organ function
* Hematologic:
* Absolute neutrophil count \> 1,500/µL
* Hemoglobin \>9 mg/dl
* Platelet count \>100,000 /µl
* Renal:
* Serum creatinine \<1.5 x Upper limit of normal (UPN) or estimated clearance \> 30 ml/min
* Hepatic:
* Serum bilirubin \< 1.5 mg/dl
You may not be if
Creatinine clearance below 30 ml/min
Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent.
Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina.
Other known co-morbidity with the potential to dominate survival
Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
Pregnant or breast feeding women
Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
Clareo Health | Biomarker Directed Treatment in Metastatic Colorectal Cancer
