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Trial record 69 of 579 for:    Advanced | cancer | bevacizumab

XELOX+Bevacizumab and XELIRI + Bevacizumab Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03511183
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Fudan University
Sun Yat-sen University
First Affiliated Hospital of Harbin Medical University
The Second Affiliated Hospital of Harbin Medical University
Liaoning Tumor Hospital & Institute
Shengjing Hospital
First Hospital of Jilin University
The First Affiliated Hospital of Dalian Medical University
Jilin Provincial Tumor Hospital
The First People's Hospital of Jingzhou
Information provided by (Responsible Party):
Yu Han, Harbin Medical University

Brief Summary:
Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time .In the past, the classical treatment regiment was to change other drug after tumor progressed. In theory, the continuous use of such a drug could shortening the patient's drug resistance time. It has been shown that the alternate use of the two drug combinations is reasonable in clinical. This application can not only further improve the curative effect but also significantly reduce the side effects. So the investigators are going to carry out a prospective phase II clinical study. The control group change to second-line treatment after progression of first-line drugs. The experimental group use the first line and the second line,alternately, for every two cycles. The combination of bevacizumab is a first line development, and the second line can still be used . Objective to compare the clinical value of XELOX + bevacizumab and XELIRI + bevacizumab alternation regimen in the first-line treatment of advanced colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Chemotherapy Drug: XELIRI + bevacizumab Drug: XELOX + bevacizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open, Controlled, Multicenter,Phase II Clinical Trial of XELOX+Bevacizumab and XELIRI + Bevacizumab Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: alternative regiment

The first stage:XELOX + bevacizumab chemotherapy and XELIRI + bevacizumab chemotherapy (alternation of every two cycles) until one of the schemes appears imaging progress or intolerance.And then enter the second stage.

The second stage: continue to apply another plan until there is progress or intolerance.

Drug: XELIRI + bevacizumab
Irinotecan,200mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle

Drug: XELOX + bevacizumab
Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle

Placebo Comparator: classical regiment
Use the XELOX + bevacizumab chemotherapy until appears imaging progress or intolerance.And then change to the XELIRI + bevacizumab chemotherapy until there is progress or intolerance.
Drug: XELIRI + bevacizumab
Irinotecan,200mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle

Drug: XELOX + bevacizumab
Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 22 months ]
    Adverse events will be evaluated according to NCI CTCAE 4.0

  2. Time to failure of strategy(TFS) [ Time Frame: 22 months ]
    Time from the beginning of the treatment until appear the following events, including death and implementation.the progress of disease,


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 22 months ]
    The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.

  2. Disease control rate(DCR) [ Time Frame: 22 months ]
    The rate of cases of remission and stable disease accounts for the total evaluable cases after treatment

  3. Overall Survival (OS) [ Time Frame: 22 months ]
    Overall survival time after the beginning of the treatment

  4. Time to failure of strategy(TFS) [ Time Frame: 22 months ]
    Time from the second beginning of the treatment until appear the following events, including death and implementation.the progress of disease,



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed as colorectal adenocarcinoma by histopathology and/or cytology.
  2. Patients could not receive surgical resection.
  3. Never received chemotherapy or radiotherapy.
  4. According to the RECIST v1.1 guide, at least 1 lesions (never received radiotherapy),accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent as the first choice),the longest diameter was more than 10mm (except for the lymph nodes, the short axis of the lymph nodes must be more than 15mm), repeated measurement.
  5. Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score
  6. The main organs function is normal, which meets the following requirements. (1) Blood routine examination,(no blood transfusion within 14 days).

    1. Hemoglobin(HB)≥90g/L;
    2. Absolute neutrophil count (ANC) ≥1.5×10^9/L;
    3. Blood platelet (PLT)≥80×10^9/L; (2) Biochemical examination should comply with the following criteria:
    1. Bilirubin(BIL) <1.5 times of the upper limit of normal value (ULN)
    2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5*ULN (liver metastasis ALT and AST<5*ULN).
    3. Serum Cr≤1*ULN, creatinine clearance rate≥50ml/min (Cockcroft-Gault formula)
  7. The expected survival time more than 3 months;
  8. The physicians plan to use XELOX + bevacizumab chemotherapy or XELIRI+bevacizumab chemotherapy.
  9. Patients voluntarily joined the study and signed informed consent form (ICF).
  10. Child bearing age women must undergo a negative pregnancy test (serum or urine) within 7 days ,and voluntarily adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug; As for men, it is necessary to receive surgical sterilization, or agree to adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug.

Exclusion Criteria:

  1. There is a case of heart disease in any of the following situations. (1)Recent publications have the following heart disease (within 6 months)

    1. Acute coronary artery syndrome
    2. Acute heart failure (grade III or IV of NYHA classification)
    3. Significant ventricular arrhythmia(sustained ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation).

      (2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patients with severe conduction block, and permanent pacemaker is invalid (two degree and three degree atrioventricular block, sinus arrest) (4)Unexplained syncope occurred within 3 months. (5)The researchers identified as uncontrol of severe hypertension, or symptomatic hypertension.

  2. There are many factors that affect the absorption of oral drugs (such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
  3. ECOG score≥2
  4. Abnormal coagulation function (INR>1.5*ULN, Activated partial thromboplastin time(APTT)>1.5*ULN), with bleeding tendency.
  5. There is any history of allergy or hypersensitivity in this research's drug or adjuvant.
  6. HIV infection and/or active hepatitis B virus infection.
  7. Any condition that may damage the safety of patients or the integrity of research data, including serious medical risk factors, physical condition and laboratory abnormality.
  8. The high risk population carrying UGT1A1*28 (7/7) *6 (A/A) genotype or simultaneous carrying of the UGT1A1*28 (6/7) *6 (A/G) genotype (the heterozygous genotype) suggests the exclusion of the Irinotecan
  9. Pregnant or lactating women;
  10. Other conditions which the doctor think not suitable for inclusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511183


Contacts
Contact: Yu Han, doctor +86-451-86298303 hanyuemail@163.com

Locations
China, Heilongjiang
Harbin Medical University Recruiting
Harbin, Heilongjiang, China
Contact: Yu Han, doctor         
Sponsors and Collaborators
Harbin Medical University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Fudan University
Sun Yat-sen University
First Affiliated Hospital of Harbin Medical University
The Second Affiliated Hospital of Harbin Medical University
Liaoning Tumor Hospital & Institute
Shengjing Hospital
First Hospital of Jilin University
The First Affiliated Hospital of Dalian Medical University
Jilin Provincial Tumor Hospital
The First People's Hospital of Jingzhou

Responsible Party: Yu Han, Chief physician, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03511183     History of Changes
Other Study ID Numbers: 2018-51-IIT
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bevacizumab
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents