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

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

NCT ID: NCT01192230

Condition: Carcinoma, Non-Small-Cell Lung

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Endostatins

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

Overall status: Unknown status

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Endostatins
Description: 7.5mg/m2 qd *14d,q3w

Intervention type: Drug
Intervention name: Docetaxel
Description: 75mg/m2 D1, q3w,4-6cycles

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:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer hospital Fudan University

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Jianhua Chang, MD,PhD

Phone: 13916619284
Email: changjianhua@hotmail.com

Start date: June 2009

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01192230