Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients

Study Overview
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Brief Summary
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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 chemotherapy.

Official Title
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A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Endostatins
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Endostatins|7.5mg/m2 qd *14d,q3w|
|Drug: Docetaxel|75mg/m2 D1, q3w,4-6cycles|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | six weeks | 
| Progression free survival |  | six weeks | 
| Overall survival |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | EORTC QLQ-C30(v3.0) | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Objective response rate, Disease control rate, Disease free survival, Overall survival, Quality of Live, Nonsmall cell lung cancer, toxicity