Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

• ClinicalTrials.gov Identifier: NCT01679327
• Recruitment Status: Unknown
• First Posted: September 6, 2012
• Last Update Posted: September 6, 2012
• Sponsor: Chinese Academy of Medical Sciences
• Information provided by (Responsible Party): yihebali chi, Chinese Academy of Medical Sciences

Tracking Information

• First Submitted Date: August 18, 2012
• First Posted Date: September 6, 2012
• Last Update Posted Date: September 6, 2012
• Study Start Date: March 2012
• Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 5, 2012)

Overall response rate [ Time Frame: 36 months ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 5, 2012)

• progression free survival [ Time Frame: 36 months ]
  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 ]
  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 ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
• Official Title: Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Cancer

Intervention

• 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

Study Arms

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)

Interventions:

• Drug: Oxaliplatin
• Drug: Xeloda
• Drug: Calcium folinate (CF)
• Drug: 5-FU
• Drug: Bevacizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 5, 2012): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2014
• Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01679327
• Other Study ID Numbers: WY0524
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: yihebali chi, Chinese Academy of Medical Sciences
• Study Sponsor: Chinese Academy of Medical Sciences
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yihebali Chi, Doctor; Chinese Academy of Medical Science
• Study Director: Jinwan WANG; Chinese Academy of Medical Science

• PRS Account: Chinese Academy of Medical Sciences
• Verification Date: September 2012