Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

NCT01679327 | Unknown Phase 2

• 1 other identifier: WY0524
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  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.

  36 months

Secondary Outcomes (3)

• progression free survival

  36 months

• overall survival

  36 months

• Number of Participants with Adverse Events

  36 months

Study Arms (1)

Bevacizumab plus chemotherapy（XELOX or FOLFOX）

EXPERIMENTAL

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

Interventions

Oxaliplatin DRUG

Also known as: Eloxatin

Bevacizumab plus chemotherapy（XELOX or FOLFOX）

Xeloda DRUG

Also known as: Capetabine

Bevacizumab plus chemotherapy（XELOX or FOLFOX）

Calcium folinate (CF) DRUG

Also known as: Calcium folinate

Bevacizumab plus chemotherapy（XELOX or FOLFOX）

5-FU DRUG

Bevacizumab plus chemotherapy（XELOX or FOLFOX）

Bevacizumab DRUG

Also known as: Avastin

Bevacizumab plus chemotherapy（XELOX or FOLFOX）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute&Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Oxaliplatin; Capecitabine; Leucovorin; Fluorouracil; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yihebali Chi, Doctor

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Jinwan WANG

  Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: August 18, 2012
• First Posted: September 6, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 6, 2012

Record last verified: 2012-09

Locations

CN (1)