Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Liaoning Tumor Hospital & Institute.
Recruitment status was  Active, not recruiting
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

December 28, 2012
January 28, 2013
September 2012
May 2013   (final data collection date for primary outcome measure)
To assess the objective response rate(ORR) [ Time Frame: 8 weeks after chemotherapy ] [ Designated as safety issue: No ]
To assess the objective response rate(ORR) [ Time Frame: 26w ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01763450 on ClinicalTrials.gov Archive Site
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 ]
To assess the R0 resection rate of liver metastases [ Time Frame: 4w,8w,12w,16w,18w,26w ] [ Designated as safety issue: No ]
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 ]
To assess the incidence of adverse events of level 3-4 (Bleeding、Gastrointestinal Perforation、Anastomotic Fistula、Hypertension、Wound Healing Delay) [ Time Frame: 2w,4w,6w,8w,10w,12w,14w,16w,18w,26w ] [ Designated as safety issue: Yes ]
 
Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer
LIAONING CANCER HOSPITAL&INSTITUTE

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.

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)
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Metastases
  • Colorectal Cancer
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;

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;

Intervention: Drug: bevacizumab plus chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
September 2014
May 2013   (final data collection date for primary outcome measure)

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;
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01763450
Avastin Study
No
Chun Song, Liaoning Tumor Hospital & Institute
Liaoning Tumor Hospital & Institute
Not Provided
Principal Investigator: Chun Song, Ph.D Professor
Liaoning Tumor Hospital & Institute
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP