A Study of FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab

Colorectal Cancer Clinical Trial

— DEEPER  

Official title:

A Randomized Phase II Study to Investigate the Deepness of Response of FOLFOXIRI Plus Cetuximab (Erbitux) Versus FOLFOXIRI Plus Bevacizumab as the First-line Therapy in Metastatic Colorectal Cancer Patients With RAS Wild-type Tumors: DEEPER

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02515734
• Other study ID #: JACCRO CC-13
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 12, 2015
• Last updated: August 4, 2015
• Start date: August 2015
• Est. completion date: June 2020

Study information

• Verified date: August 2015
• Source: Japan Clinical Cancer Research Organization
• Contact: Masashi Fujii, MD
• Phone: +81-3-5579-9882
• Email: masashi.fujii[@]gioncology.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: June 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• fluorouracil

• Leucovorin

• irinotecan

• oxaliplatin

Biological:
• bevacizumab

• cetuximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Japan Clinical Cancer Research Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best deepness of response	The maximum tumor shrinkage rates by Response Evaluation Criteria in Solid Tumors (RECIST) throughout the treatments	up to 2 years	No
Secondary	Early tumor shrinkage	The rates of tumor shrinkage by RECIST at 8 weeks	at 8 weeks	No
Secondary	Response rate		up to 2 years	No
Secondary	Deepness of response	The tumor shrinkage rates by RECIST at 4 months	at 4 months	No
Secondary	Overall survival		up to 2 years	No
Secondary	Progression free survival		up to 2 years	No
Secondary	Rate of curatively resected metastatic lesion		up to 2 years	No
Secondary	Number of adverse events		up to 2 years	Yes