NCT01832948

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 16, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

March 31, 2013

Last Update Submit

April 11, 2013

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    the end of the 3rd cycle

Secondary Outcomes (3)

  • Blood perfusion in tumor tissue

    baseline, the end of the 3rd cycle

  • Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue

    baseline, the end of the 3rd cycle

  • Incidence of Adverse Events

    up to 1 month after the last cycle

Study Arms (1)

Treatment

EXPERIMENTAL

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: EndostarDrug: OxaliplatinDrug: Folinic acidDrug: 5-FU

Interventions

EndostarDRUG
Treatment
OxaliplatinDRUG
Treatment
Folinic acidDRUG
Treatment
5-FUDRUG
Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

endostar proteinOxaliplatinLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Liming Zhu, MD

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liming Zhu, MD

CONTACT

0571-88122222

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2013

First Posted

April 16, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 16, 2013

Record last verified: 2013-04

Locations

CN(1)