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Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostar
Oxaliplatin
Folinic acid
5-FU
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma)
  • At least one measurable lesion (RECIST criteria)
  • Life expectancy ≥ 3 months
  • ECOG performance status 0-2
  • Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
  • Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min
  • Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN
  • Patients have not previously received palliative chemotherapy, immunological/ biological treatment
  • No adjuvant chemotherapy in last six months
  • Target lesion has not received local radiotherapy
  • Written informed consent

Exclusion Criteria:

  • Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma
  • Evidence of serious or uncontrolled infection
  • Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
  • Pregnant or lactating women
  • Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy
  • Allergic to any of the study drug
  • Intestinal obstruction, intestinal perforation, or stroke within 3 months
  • Participation in other clinical studies

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Secondary Outcome Measures

Blood perfusion in tumor tissue
Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue
Incidence of Adverse Events

Full Information

First Posted
March 31, 2013
Last Updated
April 11, 2013
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01832948
Brief Title
Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer
Official Title
Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h
Intervention Type
Drug
Intervention Name(s)
Endostar
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Folinic acid
Intervention Type
Drug
Intervention Name(s)
5-FU
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
the end of the 3rd cycle
Secondary Outcome Measure Information:
Title
Blood perfusion in tumor tissue
Time Frame
baseline, the end of the 3rd cycle
Title
Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue
Time Frame
baseline, the end of the 3rd cycle
Title
Incidence of Adverse Events
Time Frame
up to 1 month after the last cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma) At least one measurable lesion (RECIST criteria) Life expectancy ≥ 3 months ECOG performance status 0-2 Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN Patients have not previously received palliative chemotherapy, immunological/ biological treatment No adjuvant chemotherapy in last six months Target lesion has not received local radiotherapy Written informed consent Exclusion Criteria: Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma Evidence of serious or uncontrolled infection Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) Pregnant or lactating women Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy Allergic to any of the study drug Intestinal obstruction, intestinal perforation, or stroke within 3 months Participation in other clinical studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liming Zhu, MD
Phone
0571-88122222
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liming Zhu, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liming Zhu, MD
Phone
0571-88122222
First Name & Middle Initial & Last Name & Degree
Liming Zhu, MD

12. IPD Sharing Statement

Learn more about this trial

Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer

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