Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer

NCT01763450 | Unknown Phase 2

• 1 other identifier: Avastin Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Metastases; Colorectal Cancer

Keywords

Bevacizumab; conversion therapy; liver metastases; colorectal cancer; objective response rate

Outcome Measures

Primary Outcomes (1)

• To assess the objective response rate(ORR)

  8 weeks after chemotherapy

Secondary Outcomes (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

Other Outcomes (1)

• To assess the incidence of adverse events of level 3-4 （Bleeding、Gastrointestinal Perforation、Anastomotic Fistula、Hypertension、Wound Healing Delay）

  8 weeks after chemotherapy

Study Arms (1)

Bevacizumab plus chemotherapy

EXPERIMENTAL

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

Interventions

bevacizumab plus chemotherapy DRUG

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;

Bevacizumab plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Liaoning Cancer Hospital & Institute: lead

Study Sites (2)

Second Affiliated Hosptial of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Chun Song, Ph.D

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 8, 2013
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2014
• Last Updated: January 29, 2013

Record last verified: 2012-09

Locations

CN (2)