Trial | NCT01836653  Report issue

Title

Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases
Randomized Phase II Study of mFOLFOX6 + Bevacizumab or mFOLFOX6 + Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    122
The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.
Description: The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.
Study Started
May 31
2013
Primary Completion
Mar 31
2017
Study Completion
Mar 31
2017
Last Update
Aug 02
2017

Drug Bevacizumab

5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

  • Other names: Avastin

Drug Cetuximab

250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

  • Other names: Erbitux

Drug L-OHP

85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

  • Other names: Oxaliplatin

Drug l-LV

200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

  • Other names: Levofolinate

Drug 5-FU

400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

  • Other names: Fluorouracil

Drug 5-FU

2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

  • Other names: Fluorouracil

mFOLFOX + Bmab Experimental

mFOLFOX plus bevacizumab

mFOLFOX + Cmab Active Comparator

mFOLFOX plus cetuximab

Criteria 

Inclusion Criteria:

Histopathologically confirmed colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
RAS wild type

Synchronous* or metachronous liver limited meitastasis with no extrahepatic desiease

shychronous liver limited metastasis with primary lesion less than two thirds of the circumference
patients with primary lesion more than two thirds of the circumference can be enrolled after primary resection
Patients who has one or more lesion(s) of diameter 1 cm or larger (RECEST v1.1) be able to assess continuously on the basis of the protocol by contrast enhanced CT or contrast enhanced MRI of the liver:

(1)Liver metastases 5 or more (2)Liver metastases with 5 cm or larger in greatest dimension (3)Unresectable considering remaining hepatic function (4)Invasion into all hepatic veins or inferior vena cava (5)Invasion into both right and left hepatic arteries or portal veins 5.No prior chemotherapy for colorectal cancer including hepatic arterial infusion. Excluding postoperative and preoperative chemoradiotherapy except for rectal cancer with synchronous liver metastases. Patients received postoperative chemotherapy containing oxaliplatin have to be enrolled after 24 weeks from the last oxaliplatin administration.

6.No previous treatment including ablation therapy, cryotherapy and chemotherapy for metastases 7.Age at enrollment is >=20 and =<80 years 8.The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 9.Life expectancy from the day of enrollment is 3 months or longer 10.Major organ functions less than 14 days prior to entry meet the following criteria.

Neu >= 1500/mm3
Pt >= 10.0x10^4/mm3
Hb >= 9.0 g/dL
T-bil =< 2.0 mg/dL
AST and ALT =< 200 IU/L
sCr =< 1.20 mg/dL
INR < 1.5
Proteinuria =< 2+ 11.Written informed consent

Exclusion Criteria:

Previously experienced severe allergic reaction to drugs
Receiving anti-platelet drugs (aspirin >= 325 mg/day) or NSAIDs
Receiving chronic systemic corticosteroid treatment
Surgery/ biopsy with skin incision or traumatic injury with suture less than 14 days prior to entry. Excluding, suture for implanted venous reservoirs with catherter is allowed.
Severe postoperative complications (e.g. postoperative infection, anastomic dehiscence or paralytic ileus)
Diagnosed as hereditary colorectal cancer
Active other malignancies
Cerebrovascular disease or symptoms less than 1 year prior to entry
Pleural effusion, ascites or cardiac effusion requiring drainage
Hemorrhage/bleeding, paralytic ileus, obstruction or ulceration of gastrointestinal tract
Perforation of gastrointestinal tract less than 1 year prior to entry
Presence of active infection
HBs antigen or HCV antibody positive
Uncontrolled comorbidity including hypertension, diabetes, arrhythmia, or other diseases (such as cardiac disorder, interstitial pneumonia or renal disorder)
Presence of >= grade 2 diarrhea
Presence of >= grade 1 peripheral neuropathy
Pregnant or lactating women. Women and men with childbearing potential unwilling to use effective means of contraception
Psychosis or psychiatric symptoms who are not able to comply with the protocol
Any other medical conditions disable to comply with the protocol
No Results Posted