Status:
UNKNOWN
Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
Lead Sponsor:
Fudan University
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line ch...
Eligibility Criteria
Inclusion
- Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer
- ≥ 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
- Patients who have previously received Docetaxel or anti-VEGF inhibitors
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01192230
Start Date
June 1 2009
Last Update
September 16 2010
Active Locations (1)
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1
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032