Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00657423
NCT00657423UnknownPhase 3

Study of Endostar Combined With Docetaxel and Cisplatin on the Angiogenesis of Advanced Non-small Cell Lung Cancer

Xijing Hospital1 site in 1 country80 target enrollmentStarted: April 2008Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
mean survival time
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Detailed Description

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 experimental group(endostar combined with docetaxel and cisplatin) and the control group (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.
  • the clinical parameters such as objective response rate (ORT),time to progression(TTP) and mean survival time(MST) will be collected according to the WHO criteria.
  • the toxicity will be recorded according to the NCI-CTC v3.0.
  • the Quality of life was self-assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire.
  • 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 ORT, TTP, MST, toxicity and QOL.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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
  • •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.

Exclusion Criteria

  • •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
  • •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.

Arms & Interventions

1

Experimental

Intervention: Treated by endostar combined with docetaxel and cisplatin (Drug)

2

Active Comparator

Intervention: Treated by docetaxel and cisplatin (Drug)

Outcomes

Primary Outcomes

mean survival time

Time Frame: 1 year

Secondary Outcomes

  • objective response rate(1 year)

Investigators

Sponsor
Xijing Hospital
Sponsor Class
Other

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Phase 2
Oxaliplatin, Capecitabine and Endostar as First Line Treatment for Patients With Advanced Colorectal CancerAdvanced Colorectal Cancer
NCT00853684Shanghai Jiao Tong University School of Medicine44
Unknown
Phase 2
A phase II study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.advanced gastric cancer
JPRN-UMIN000000801Dept. of Internal Medicine(4)30
Completed
Phase 2
Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)on-small sell lung carcinoma (NSCLC)
JPRN-C000000310The Tokyo cooperative oncology group150
Completed
Phase 2
Phase II study of the combination of docetaxel, cisplatin plus S-1(DCS) for advanced or recurrent gastric cancer(KDOG 0601)Gastric cancer
JPRN-UMIN000001119Department of Gastroenterology, Kitasato University School of Medicine45
Completed
Phase 2
Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic CancerMetastatic Pancreatic Carcinoma
NCT00137761Dana-Farber Cancer Institute32