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

Phase 2

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT01192230
• Lead Sponsor: Fudan University

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 chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Status Verified: 2010-08
• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-01
• Last Update Submitted: 2010-09-15
• Last Update Posted: 2010-09-16
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	six weeks
Progression free survival	six weeks
Overall survival	three months

Secondary Outcome Measures

Name	Time	Method
Quality of Life	six weeks	EORTC QLQ-C30(v3.0)

Trial Locations

Locations (1)

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China