A Study of FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Cancer Research Organization
• Treatments: Bevacizumab; Cetuximab; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

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