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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Docetaxel; Endostatins

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