Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: A Study of FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab

Summary: This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors.

Detailed description: This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors. In this study the investigators employed deepness of response as a primary endpoint.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed colorectal cancer
  -  RAS wild-type
  -  Measurable lesion by RECIST (Ver.1.1)
  -  No past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.In the case of recurrence, no treatment for the first recurrence lesion after operation
  -  Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.The case >=71 years is PS0.
  -  Life expectancy of more than 6 months
  -  Patients have enough organ function for study treatment within 14 days before enrollment;
  1. White blood cell (WBC)>=3,000/mm3, <12,000/mm3.
  2. Neu>=1,500/mm3.
  3. Platelet count (PLT) >=10.0x104/mm3.
  4. Hb>=9.0g/dL.
  5. Total Bilirubin<=1.5x Upper Limited Normal (ULN)
  6. aspartate aminotransferase (AST) <=2.5xULN.
  7. alanine aminotransferase (ALT) <=2.5xULN.
  8. Creatinine<=1.5xULN.
  9. Proteinuria<=1+.
  10. prothrombin time-international normalized ratio (PT-INR) <=1.5
  -  Must be able to swallow tablets
  -  Written informed consent
  Exclusion Criteria:
  -  Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
  -  Lynch syndrome
  -  Brain metastases
  -  Infectious disease
  -  Interstitial lung disease or pulmonary fibrosis
  -  Comorbidity or history of serious heart failure
  -  History of thromboembolic events
  -  Cerebrovascular disease
  -  History of hemoptysis/hematemesis
  -  Uncontrolled hypertension (systolic BP>180mmHg, or diastolic BP>100mmHg)
  -  Sensory alteration or paresthesia interfering with function
  -  Large quantity of pleural, abdominal or cardiac effusion
  -  Severe comorbidity (renal failure, liver failure, hypertension, etc)
  -  Prior radiotherapy for primary and metastases leision
  -  Men/women who are unwilling to avoid pregnancy
  -  Women who are pregnant or breastfeeding
  -  Women with a positive pregnancy test
  -  History of severe allergy
  -  HBsAg positive or active viral hepatitis
  -  Administration of blood products/ Granulocyte-Colony Stimulating Factor (G-CSF), and blood transfusion within 14 days
  -  Surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgery within 28 days
  -  Systematic administration of antiplatelet drug or non steroid anti-inflammatory drugs (NSAIDs)
  -  Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy
  -  History of gastrointestinal perforation within 1 year
  -  Unhealed traumatic bone fracture
  -  Uncontrolled diarrhea
  -  History of organ recipient
  -  Prior cetuximab/bevacizumab/Irinotecan/Oxaliplatin treatment (Adjuvant therapy by Oxaliplatin is excluded)
  -  Administration of atazanavir sulfate
  -  Jaundice
  -  Ileus or bowel obstruction
  -  Clinical diagnosis of Alzheimer's Disease
  -  Insulin dependent diabetes
  -  Thyroid disease
  -  Any other cases who are regarded as inadequate for study enrollment by investigators

Relevance to patient case: not relevant