Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
NCT ID: NCT01192230
Last Updated: 2010-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Endostatins
7.5mg/m2 qd \*14d,q3w
Docetaxel
75mg/m2 D1, q3w,4-6cycles
Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years old
* patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled
* At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
* have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy
* ECOG 0-2
* Expected life time longer than 3 months
* Normal laboratory values:
* leucocyte≥ 4×109/L
* neutrophil≥ 1.5×109/L
* platelet≥90×109/L
* Hemoglobin≥ 9g/L
* ALT and AST ≤3×ULN (≤5×ULN if liver metastasis)
* serum creatinine\<1.5 mg/dl
* bilirubin \<1.5×ULN
* No allergy to biological drug
* Sign the consent forms
Exclusion Criteria
* Severe symptomatic heart disease
* Female patients during their pregnant and lactation period, or patients without contraception
* Severe uncontrolled infection
* Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor
* Patients with other malignant tumor,except for basal cell carcinoma,squamous cell carcinoma and carcinoma in situ
* Patients have accepted other clinical trials
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Department of Medical Oncology,Fudan University Cancer Hospital
Principal Investigators
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Jianhua Chang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University affiliated cancer hospital
Locations
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Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EndoDocNSCLC
Identifier Type: -
Identifier Source: org_study_id