Clinical trial · Interventional

A Study of FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab

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

NCT02515734CI-TRIAL-00018768DEEPERunknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
bevacizumab	Biological	Bevacizumab	ALIAS
cetuximab	Biological	Cetuximab	ALIAS
fluorouracil	Drug	Fluorouracil	ALIAS
irinotecan	Drug	Irinotecan	ALIAS
Leucovorin	Drug	Leucovorin	ALIAS
oxaliplatin	Drug	Oxaliplatin	ALIAS

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
FOLFOXIRI+Bmab
description
Patients 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.
interventionNames
1. Drug: fluorouracil
2. Drug: Leucovorin
3. Drug: irinotecan
4. Drug: oxaliplatin
5. Biological: bevacizumab
type
EXPERIMENTAL
label
FOLFOXIRI+Cmab
description
Patients 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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 20 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.