Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT01679327
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
  • Xeloda — DRUG
  • Calcium folinate (CF) — DRUG
  • 5-FU — DRUG
  • Bevacizumab — DRUG

Study Details

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.

Key Dates

First listed
Sep 6, 2012
Start date
Mar 31, 2012
Status verified
Sep 2012
Primary completion
Jun 30, 2014
Completion
Sep 30, 2014

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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)

Primary Outcome Measure

Overall response rate [ Time Frame: 36 months ]

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