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Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer

Primary Purpose

Liver Metastases, Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
bevacizumab plus chemotherapy
Sponsored by
Liaoning Tumor Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastases focused on measuring Bevacizumab, conversion therapy, liver metastases, colorectal cancer, objective response rate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written inform consent form
  2. histologically or cytologically confirmed Colorectal Adenocarcinoma
  3. Age≥18 and ≤80 years old
  4. Primary colorectal cancer and liver metastases,Liver lesions determined to be unresectable by multidisciplinary team (MDT) (primary lesions surgically removed)
  5. Simultaneity or heterochrony metastases
  6. Colorectal cancer lesions from anal edge at least 8 cm
  7. Within 6 months did not receive any chemotherapy, including targeted therapy
  8. One or more measurable lesions, conventional Computed Tomography(CT) scanning measurement diameter at least 20 mm [Response Evaluation Criteria In Solid Tumors(RECIST) standard]
  9. Eastern Collaborative Oncology Group(ECOG) 0 or 1
  10. Expected lifetime at least for 12 weeks
  11. Screening within 7 days, the ability of bone marrow, liver and kidney function reserve enough;Absolute neutrophil count(ANC)≥1.5x109/L; hemoglobin≥9.0g/dl; platelet count≥80 x109/L; Total Bilirubin(TBil)≤1.5 x upper level of normal range(ULN); Alanine Aminotransferase(ALT) and Aspartate Aminotransferase(AST)≤2.5 x ULN(Patients with hepatic metastasis≤5x ULN); alkaline phosphatase≤4 x ULN; serum creatinine≤1.5 x ULN;
  12. Women of reproductive age should take effective contraceptive measures;

Exclusion Criteria:

  1. Arrhythmia requiring medication(except β- receptor blocking pharmacon and digoxigenin),symptomatic coronary artery disease and myocardial ischemia [myocardial infarction (≤6months before enrollment)],congestive heart failure [≥New York Heart Association(NYHA)2];
  2. History of HIV infection,Chronic hepatitis B or hepatitis C of active phase(high copy virus DNA);
  3. Other activated serious infection [>National Cancer Institute-Common Toxicity Criteria(NCI-CTC) 3.0];
  4. Any extrahepatic metastases;
  5. Seizures requiring medication(such as steroids or antiepileptic therapy);
  6. Other malignancies in the past 5 years (except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix);
  7. Chronic inflammatory bowel disease, intestinal obstruction;
  8. Drug abuse and medicine, psychology or social conditions may interfere with patients to participate in research or the results of the evaluation have influence;
  9. Known or suspected allergy to any investigational drug in this study;
  10. Any unstable condition or is likely to endanger the patient safety and compliance situation;
  11. Pregnant or lactating women not using or refusing to use effective non hormonal means of contraception;

Sites / Locations

  • Second Affiliated Hosptial of Harbin Medical University
  • Liaoning Cancer Hospital&Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab plus chemotherapy

Arm Description

Bevacizumab: 7.5mg/kg, iv, on day 1 of each 21 day cycle or 5mg/kg, iv, on day 1 of each 14 day cycle; Oxaliplatin+capecitabine(XELOX):( The total dose not less than 70% of the recommended dose of this standard) Oxaliplatin: 130mg/m2,d1; capecitabine: 850-1,000mg/m2,d1-d14, bid,each 21 day cycle; Oxaliplatin+5-Fluorouracil+ Levomisole(FOLFOX): Oxaliplatin: 85mg/m2,iv for 2 hours ,d1; Levomisole(LV): 400mg/m2,iv for 2 hours,d1; 5-Fluorouracil(5-FU) :400mg/m2 iv,d1,then 1200mg/m2/d ×2d continuous intravenous infusion(volume dose:2400mg/m2,iv for 46-48 hours ) each 14 day cycle;

Outcomes

Primary Outcome Measures

To assess the objective response rate(ORR)

Secondary Outcome Measures

To assess the R0 resection rate of liver metastases

Full Information

First Posted
December 28, 2012
Last Updated
January 28, 2013
Sponsor
Liaoning Tumor Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01763450
Brief Title
Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer
Official Title
LIAONING CANCER HOSPITAL&INSTITUTE
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaoning Tumor Hospital & Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A multi-center, non-random, open study ,to observe efficacy and safety of bevacizumab plus Oxaliplatin based multidrug chemotherapy as conversion therapy for patients with previously untreated unresectable liver metastases from colorectal cancer.
Detailed Description
PRIMARY OBJECTIVES:To assess the objective response rate(ORR)(8 weeks after chemotherapy) SECONDARY OBJECTIVES: To assess the R0 resection rate of liver metastases(8 weeks after chemotherapy、every three months follow-up 1 time in R0 postoperative 1-2 years、Every six months follow-up 1 time in R0 postoperative 2-5 years) To assess the incidence of adverse events of level 3-4 (Bleeding、Gastrointestinal Perforation、Anastomotic Fistula、Hypertension、Wound Healing Delay)(8 weeks after chemotherapy)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases, Colorectal Cancer
Keywords
Bevacizumab, conversion therapy, liver metastases, colorectal cancer, objective response rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab plus chemotherapy
Arm Type
Experimental
Arm Description
Bevacizumab: 7.5mg/kg, iv, on day 1 of each 21 day cycle or 5mg/kg, iv, on day 1 of each 14 day cycle; Oxaliplatin+capecitabine(XELOX):( The total dose not less than 70% of the recommended dose of this standard) Oxaliplatin: 130mg/m2,d1; capecitabine: 850-1,000mg/m2,d1-d14, bid,each 21 day cycle; Oxaliplatin+5-Fluorouracil+ Levomisole(FOLFOX): Oxaliplatin: 85mg/m2,iv for 2 hours ,d1; Levomisole(LV): 400mg/m2,iv for 2 hours,d1; 5-Fluorouracil(5-FU) :400mg/m2 iv,d1,then 1200mg/m2/d ×2d continuous intravenous infusion(volume dose:2400mg/m2,iv for 46-48 hours ) each 14 day cycle;
Intervention Type
Drug
Intervention Name(s)
bevacizumab plus chemotherapy
Intervention Description
Bevacizumab: 7.5mg/kg, iv, on day 1 of each 21 day cycle or 5mg/kg, iv, on day 1 of each 14 day cycle; Oxaliplatin+capecitabine(XELOX):( The total dose not less than 70% of the recommended dose of this standard) Oxaliplatin: 130mg/m2,d1; capecitabine: 850-1,000mg/m2,d1-d14, bid,each 21 day cycle; Oxaliplatin+5-Fluorouracil+ Levomisole(FOLFOX): Oxaliplatin: 85mg/m2,iv for 2 hours ,d1; Levomisole(LV): 400mg/m2,iv for 2 hours,d1; 5-Fluorouracil(5-FU) :400mg/m2 iv,d1,then 1200mg/m2/d ×2d continuous intravenous infusion(volume dose:2400mg/m2,iv for 46-48 hours ) each 14 day cycle;
Primary Outcome Measure Information:
Title
To assess the objective response rate(ORR)
Time Frame
8 weeks after chemotherapy
Secondary Outcome Measure Information:
Title
To assess the R0 resection rate of liver metastases
Time Frame
8 weeks after chemotherapy、every three months follow-up 1 time in R0 postoperative 1-2 years、Every six months follow-up 1 time in R0 postoperative 2-5 years
Other Pre-specified Outcome Measures:
Title
To assess the incidence of adverse events of level 3-4 (Bleeding、Gastrointestinal Perforation、Anastomotic Fistula、Hypertension、Wound Healing Delay)
Time Frame
8 weeks after chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written inform consent form histologically or cytologically confirmed Colorectal Adenocarcinoma Age≥18 and ≤80 years old Primary colorectal cancer and liver metastases,Liver lesions determined to be unresectable by multidisciplinary team (MDT) (primary lesions surgically removed) Simultaneity or heterochrony metastases Colorectal cancer lesions from anal edge at least 8 cm Within 6 months did not receive any chemotherapy, including targeted therapy One or more measurable lesions, conventional Computed Tomography(CT) scanning measurement diameter at least 20 mm [Response Evaluation Criteria In Solid Tumors(RECIST) standard] Eastern Collaborative Oncology Group(ECOG) 0 or 1 Expected lifetime at least for 12 weeks Screening within 7 days, the ability of bone marrow, liver and kidney function reserve enough;Absolute neutrophil count(ANC)≥1.5x109/L; hemoglobin≥9.0g/dl; platelet count≥80 x109/L; Total Bilirubin(TBil)≤1.5 x upper level of normal range(ULN); Alanine Aminotransferase(ALT) and Aspartate Aminotransferase(AST)≤2.5 x ULN(Patients with hepatic metastasis≤5x ULN); alkaline phosphatase≤4 x ULN; serum creatinine≤1.5 x ULN; Women of reproductive age should take effective contraceptive measures; Exclusion Criteria: Arrhythmia requiring medication(except β- receptor blocking pharmacon and digoxigenin),symptomatic coronary artery disease and myocardial ischemia [myocardial infarction (≤6months before enrollment)],congestive heart failure [≥New York Heart Association(NYHA)2]; History of HIV infection,Chronic hepatitis B or hepatitis C of active phase(high copy virus DNA); Other activated serious infection [>National Cancer Institute-Common Toxicity Criteria(NCI-CTC) 3.0]; Any extrahepatic metastases; Seizures requiring medication(such as steroids or antiepileptic therapy); Other malignancies in the past 5 years (except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix); Chronic inflammatory bowel disease, intestinal obstruction; Drug abuse and medicine, psychology or social conditions may interfere with patients to participate in research or the results of the evaluation have influence; Known or suspected allergy to any investigational drug in this study; Any unstable condition or is likely to endanger the patient safety and compliance situation; Pregnant or lactating women not using or refusing to use effective non hormonal means of contraception;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Song, Ph.D
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hosptial of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
Facility Name
Liaoning Cancer Hospital&Institute
City
Shenyang
State/Province
Liaoning
Country
China

12. IPD Sharing Statement

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Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer

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