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Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

This study is currently recruiting participants.
Verified September 2012 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
yihebali chi, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01679327
First received: August 18, 2012
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
  Purpose

This study evaluates the relationship of biomarker expression and efficacy of bevacizumab plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3 expression in tumor tissue by IHC and detect those protein expression level in plasma by ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D expression level in plasma by ELISA. The aim of the study is to identify whether those biomarkers could predict Bevacizumab efficacy.


Condition Intervention Phase
Colorectal Cancer
 Drug: Oxaliplatin
Drug: Xeloda
Drug: Calcium folinate (CF)
Drug: 5-FU
Drug: Bevacizumab
 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: Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    During the chemotherapy,all the patients demonstrate CT scan or MR to evaluate tumor response to therapy every two cycles.According to RECIST 1.1,tumor response was recorded.


Secondary Outcome Measures:
  • progression free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    The start time point was defined as when patients receive the first cycle chemotherapy.The end time point was defined as When tumor response to therapy was evaluated as PD according to RECIST 1.1 or patients die for any reason.

  • overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    From the time patients receive the first cycle chemotherapy to the time they die for any reason.

  • Number of Participants with Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    Every cycle we demonstrate routine blood test,routine urine test,routine stool test,blood biochemical test.We recommend patients take blood pressure at least twice a week during the therapy.If needed,patients also need have electrocardiogram test and echocardiography.We will evaluate the toxicity according to CTCAE4.0


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab plus chemotherapy（XELOX or FOLFOX）
Bevacizumab plus XELOX (Bevacizumab 7.5mg/kg d1;Xeloda 2g/m2 d1-14 divided into two times;Oxaliplatin 130mg/m2 d1;repeated in 21 days) Bevacizumab plus FOLFOX (Oxaliplatin 85mg/ m2 ivgtt d1;CF 200mg/ m2 ivgtt d1;Bevacizumab 5mg/kg ivgtt d1 5-FU 400mg /m2 ivgtt d1;5-FU 2400mg/m2 CIV 48h;repeated in 14 days)
 Drug: Oxaliplatin
Other Name: Eloxatin
Drug: Xeloda
Other Name: Capetabine
Drug: Calcium folinate (CF)
Other Name: Calcium folinate
Drug: 5-FU Drug: Bevacizumab
Other Name: Avastin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • More than 18-years old,male or female
  • Pathologically approved as unresectable/metastatic colorectal cancer
  • KPS > 70% or ECOG 0-2
  • HGB > 80 g/L, NEUT ≥ 1.5x109 /L, PLT ≥ 80x109 /L; CR < 1.5 x Upper normality，
  • TB < 1.5 X Upper normality，AST or ALT < 2.5 x Upper normality.
  • Signed consent

Exclusion Criteria:

  • Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer
  • Pregnancy or in lactation
  • HGB < 80 g/L, NEUT < 1.5x109 /L, PLT < 80x109 /L; CR ≥ 1.5 x Upper normality， TB ≥ 2.5 X Upper normality，AST or ALT ≥2.5 x Upper normality，AKP ≥ 2.5 X Upper normality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679327

Locations
China
Cancer Institute&Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Yihebali Chi, MD     8610-87788145     Yihebalichi@yahoo.com    
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Yihebali Chi, Doctor Chinese academy of medical science
Study Director: Jinwan WANG Chinese academy of medical science
  More Information

No publications provided

Responsible Party: yihebali chi, associated professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01679327     History of Changes
Other Study ID Numbers: WY0524
Study First Received: August 18, 2012
Last Updated: September 5, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium, Dietary
Leucovorin
Bevacizumab
Levoleucovorin
 Oxaliplatin
Capecitabine
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013