Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)

Non Small Cell Lung Cancer Clinical Trial

Official title:

Single-center, Open Trail of Phase 1 of M2ES With TC Regimen in Advanced NSCLC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099124
• Other study ID #: TMU-CIH-CTI-001
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: January 28, 2013
• Start date: December 2009
• Est. completion date: September 2011

Study information

• Verified date: April 2010
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Aged 18-70 years old;

2. Patients with ?/? NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;

3. No contraindication for chemotherapy;

4. ECOG performance scale 0-2;

5. No history of anti-angiogenesis therapy;

6. Patients are voluntary to participate and sigh the informed contents.

Exclusion Criteria:

1. Concurrent use of other anti-cancer agents;

2. Allergic history to M2ES and biological agents;

3. Pregnant or breast-feeding women;

4. With other malignancy;

5. With severe cardiopulmonary disease;

6. Uncontrolled brain metastasis patients;

7. Other conditions that are regarded for exclusion by the trialists.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• M2ES
polyethylene glycol rh recombinant endostatin

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institude and Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events incidence,including severe adverse events incidence		one year	Yes
Secondary	Tumor response rate and disease controlled rate		one year	Yes