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

April 11, 2013 updated by: Zhejiang Cancer Hospital

Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Liming Zhu, MD
          • Phone Number: 0571-88122222
        • Principal Investigator:
          • Liming Zhu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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
Drug: Oxaliplatin
Drug: 5-FU
Drug: Folinic acid
Drug: Endostar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: the end of the 3rd cycle
the end of the 3rd cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood perfusion in tumor tissue
Time Frame: baseline, the end of the 3rd cycle
baseline, the end of the 3rd cycle
Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue
Time Frame: baseline, the end of the 3rd cycle
baseline, the end of the 3rd cycle
Incidence of Adverse Events
Time Frame: up to 1 month after the last cycle
up to 1 month after the last cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Liming Zhu, MD, Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

March 31, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20121201E-mCRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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