Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-small Cell Lung Cancer(NSCLC): a Randomized, Double-blind, Placebo-controlled, Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708812
• Other study ID #: XYL014
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2008
• Last updated: July 20, 2011
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2011
• Source: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus TC or TC alone for 3 cycles, 21 days as one cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• histologically or cytologically confirmed, previously untreated stage IIIB or IV NSCLC

• age of 18-75 years

• at least one measurable lesion (RECIST)

• patients evaluated as SD or above after 1 cycle (21 days) of TC chemotherapy .

• adequate hematologic, cardiac, renal, and hepatic function

• ECOG PS 0-2

Exclusion Criteria:

• symptomatic brain metastases

• bone metastases with complications

• major organ dysfunction

• bleeding diathesis or coagulopathy

• pregnant or lactating woman

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• Endostar(Recombinant Human Endostatin Injection)
Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle
• paclitaxel-carboplatin
paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)		every 2 months until disease progression	No
Secondary	Objective Response Rate (ORR)		the end of each cycle	No
Secondary	Overall Survival (OS)		2 years	No