A Study of FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab
DEEPER
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
1 other identifier
interventional
360
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Aug 2015
Typical duration for phase_2 colorectal-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 5, 2015
August 1, 2015
2.3 years
July 12, 2015
August 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best deepness of response
The maximum tumor shrinkage rates by Response Evaluation Criteria in Solid Tumors (RECIST) throughout the treatments
up to 2 years
Secondary Outcomes (7)
Early tumor shrinkage
at 8 weeks
Response rate
up to 2 years
Deepness of response
at 4 months
Overall survival
up to 2 years
Progression free survival
up to 2 years
- +2 more secondary outcomes
Study Arms (2)
FOLFOXIRI+Bmab
ACTIVE COMPARATORPatients in the FOLFOXIRI + Bmab group receive until 12 cycles of FOLFOXIRI plus bevacizumab, consisting of a 30-minute infusion of bevacizumab at a dose of 5 mg per kilogram, a 60-minute infusion of irinotecan at a dose of 150 mg per square meter, and a 120-minute infusion of oxaliplatin at a dose of 85 mg per square meter and a concomitant 120-minute infusion of leucovorin at a dose of 200 mg per square meter, followed by a 48-hour continuous infusion of fluorouracil to a total dose of 2400 mg per square meter. Cycles were repeated every 14 days. After 13 cycles, patients receive fluorouracil, leucovorin and bevacizumab every 14 days until disease progression.
FOLFOXIRI+Cmab
EXPERIMENTALPatients in the experimental group received until 12 cycles of FOLFOXIRI plus cetuximab, consisting of a 30-minute infusion of cetuximab first time at a dose of 400 mg per kilogram, after the second time at a dose of 250mg per kilogram, a 60-minute infusion of irinotecan at a dose of 150 mg per square meter, and a 120-minute infusion of oxaliplatin at a dose of 85 mg per square meter and a concomitant 120-minute infusion of leucovorin at a dose of 200 mg per square meter, followed by a 48-hour continuous infusion of fluorouracil to a total dose of 2400 mg per square meter. Cycles were repeated every 14 days. After 13 cycles, patients receive fluorouracil, leucovorin and cetuximab every 14 days until disease progression.
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- White blood cell (WBC)\>=3,000/mm3, \<12,000/mm3.
- Neu\>=1,500/mm3.
- Platelet count (PLT) \>=10.0x104/mm3.
- Hb\>=9.0g/dL.
- Total Bilirubin\<=1.5x Upper Limited Normal (ULN)
- aspartate aminotransferase (AST) \<=2.5xULN.
- alanine aminotransferase (ALT) \<=2.5xULN.
- Creatinine\<=1.5xULN.
- +4 more criteria
You may not qualify if:
- 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
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Toshifusa Nakajima, MD
Japan Clinical Cancer Research Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2015
First Posted
August 5, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2017
Study Completion
June 1, 2020
Last Updated
August 5, 2015
Record last verified: 2015-08