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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01192230
• Other study ID #: EndoDocNSCLC
• Status: Recruiting
• Phase: Phase 2
• First received: August 4, 2010
• Last updated: September 15, 2010
• Start date: June 2009

Study information

• Verified date: August 2010
• Source: Fudan University
• Contact: Jianhua Chang, MD,PhD
• Phone: 13916619284
• Email: changjianhua[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Endostatins
7.5mg/m2 qd *14d,q3w
• Docetaxel
75mg/m2 D1, q3w,4-6cycles

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		six weeks	Yes
Primary	Progression free survival		six weeks	No
Primary	Overall survival		three months	No
Secondary	Quality of Life	EORTC QLQ-C30(v3.0)	six weeks	Yes