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Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
Conditions
Carcinoma, Non-Small-Cell Lung
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Objective response rate, Disease control rate, Disease free survival, Overall survival, Quality of Live, Nonsmall cell lung cancer, toxicity
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Endostatins
Type: Drug
Name: Docetaxel
Type: Drug
Overall Status
Recruiting
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 chemotherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Cancer hospital Fudan University
Shanghai, Shanghai, China
Status: Recruiting
Contact: Jianhua Chang, MD,PhD - 13916619284 - changjianhua@hotmail.com
Start Date
June 2009
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page