Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer
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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 |
- To assess the objective response rate(ORR) [ Time Frame: 8 weeks after chemotherapy ] [ Designated as safety issue: No ]
- 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 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
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
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:
- 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)
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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;
Contacts and Locations| China, Heilongjiang | |
| Second Affiliated Hosptial of Harbin Medical University | |
| Harbin, Heilongjiang, China, 150086 | |
| China, Liaoning | |
| Liaoning Cancer Hospital&Institute | |
| Shenyang, Liaoning, China | |
| 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 May 23, 2013