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

NCT01192230 | Unknown Phase 2

• 1 other identifier: EndoDocNSCLC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Objective response rate; Disease control rate; Disease free survival; Overall survival; Quality of Live; Nonsmall cell lung cancer; toxicity

Outcome Measures

Primary Outcomes (3)

• Response rate

  six weeks

• Progression free survival

  six weeks

• Overall survival

  three months

Secondary Outcomes (1)

• Quality of Life

  six weeks

Interventions

Endostatins DRUG

7.5mg/m2 qd \*14d,q3w

Docetaxel DRUG

75mg/m2 D1, q3w,4-6cycles

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Endostatins; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jianhua Chang, MD,PhD

  Fudan University affiliated cancer hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Chang, MD,PhD

CONTACT

13916619284; changjianhua@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: September 1, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Last Updated: September 16, 2010

Record last verified: 2010-08

Locations

CN (1)