NCT00657423

Brief Summary

To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of non-small cell lung cancer, patients will be randomly assigned to the group one (endostar combined with docetaxel and cisplatin) and group two (docetaxel and cisplatin).

  • The serum concentrations of Endostatin,VEGF and bFGF are determined.
  • Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor cells (CPCs) will be measured by flow cytometer.
  • Statistical analysis will be applied to study the relationship between the levels of Endostatin, VEGF, bFGF, CECs and CPCs and the clinical outcomes such as objective response rate(ORT), time to progression (TTP), mean survival time(MST), toxicity and quality of life (QOL).

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
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

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

April 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 17, 2010

Status Verified

August 1, 2008

Enrollment Period

8 months

First QC Date

April 9, 2008

Last Update Submit

September 15, 2010

Conditions

Lung Neoplasms

Keywords

Lung NeoplasmsEndostatinsVascular Endothelial Growth FactorsFibroblast Growth FactorsSurvival Rate

Outcome Measures

Primary Outcomes (1)

  • mean survival time

    1 year

Secondary Outcomes (1)

  • objective response rate

    1 year

Study Arms (2)

1

EXPERIMENTAL
Drug: Treated by endostar combined with docetaxel and cisplatin

2

ACTIVE COMPARATOR
Drug: Treated by docetaxel and cisplatin

Interventions

Treated by endostar combined with docetaxel and cisplatinDRUG

recombinant human endostatin given intravenously,7.5mg/㎡,d1-14,2cycles. docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.

Also known as: Endostar, Taxotere
1
Treated by docetaxel and cisplatinDRUG

docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.

Also known as: Taxotere
2

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of advanced or metastatic NSCLC (confirmed histologically, with a tumor that was measurable by clinical and/or radiologic examination.
  • Have an Eastern Cooperative Oncology Group performance status 0 to 2.
  • Adequate renal, cardiac, hepatic, and hematologic function as indicated by the following parameters: absolute neutrophil count 2 x the ninth power of ten/L, thrombocytes 100 x the ninth power of ten/L, hemoglobin 10 g/dL, total bilirubin 1.25x the upper limit of normal range (ULN), ALT and AST 1.5x ULN, alkaline phosphatase 5x ULN, creatinine 1.15x ULN.

You may not qualify if:

  • Known brain metastases or secondary neoplasia.
  • Myocardial insufficiency or myocardial infarction within the preceding 6 months.
  • Severe renal or hepatic insufficiency.
  • Pre-existing motor or sensor neurotoxicity WHO grade 2.
  • Severe psychologic disease.
  • Active infection, or other condition that could compromise protocol compliance.
  • Simultaneous administration of other antineoplastic medications.
  • Clinically significant hemoptysis.
  • Pregnancy and/or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Resp. Diseases, Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

DocetaxelCisplatinendostar protein

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Changgui Wu, MD, PHD

    Dept. Resp. Diseases, Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengqing Li, MD, PHD

CONTACT

086-029-84771132shengqingli@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2008

First Posted

April 14, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

September 17, 2010

Record last verified: 2008-08

Locations

CN(1)