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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Endostatins; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01192230

EndoDocNSCLC

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)