Status:
UNKNOWN
Impact of Endostar Combined With Chemotherapy on the Angiogenesis of Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
Yantai Medgenn Ltd.
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 doc...
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 w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00657423
Start Date
April 1 2008
End Date
April 1 2009
Last Update
September 17 2010
Active Locations (1)
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1
Dept. Resp. Diseases, Xijing Hospital
Xi'an, Shaanxi, China, 710032