Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chun Song, Liaoning Tumor Hospital & Institute
ClinicalTrials.gov Identifier:
NCT01763450
First received: December 28, 2012
Last updated: January 28, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Liver Metastases
Colorectal Cancer
Drug: bevacizumab plus chemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LIAONING CANCER HOSPITAL&INSTITUTE

Resource links provided by NLM:


Further study details as provided by Liaoning Tumor Hospital & Institute:

Primary Outcome Measures:
  • To assess the objective response rate(ORR) [ Time Frame: 8 weeks after chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab plus chemotherapy
  1. 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;

  2. 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;
  3. 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;

Drug: bevacizumab plus chemotherapy
  1. 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;

  2. 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;
  3. 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;


Detailed Description:

PRIMARY OBJECTIVES:To assess the objective response rate(ORR)(8 weeks after chemotherapy)

SECONDARY OBJECTIVES:

  1. 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)
  2. To assess the incidence of adverse events of level 3-4 (Bleeding、Gastrointestinal Perforation、Anastomotic Fistula、Hypertension、Wound Healing Delay)(8 weeks after chemotherapy)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763450

Locations
China, Heilongjiang
Second Affiliated Hosptial of Harbin Medical University
Harbin, Heilongjiang, China, 150086
China, Liaoning
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China
Sponsors and Collaborators
Liaoning Tumor Hospital & Institute
Investigators
Principal Investigator: Chun Song, Ph.D Professor
  More Information

No publications provided

Responsible Party: Chun Song, Professor, Liaoning Tumor Hospital & Institute
ClinicalTrials.gov Identifier: NCT01763450     History of Changes
Other Study ID Numbers: Avastin Study
Study First Received: December 28, 2012
Last Updated: January 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Liaoning Tumor Hospital & Institute:
Bevacizumab
conversion therapy
liver metastases
colorectal cancer
objective response rate

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Fluorouracil
Capecitabine
Oxaliplatin
Bevacizumab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014