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Paclitaxel Plus Carboplatin With Endostar in Patients of Advanced Non-Small Cell Lung Cancer

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Treatment

Active

18 to 75

Pharmaceutical / Industry

XYL014
NCT00708812

Trial Description

Summary

In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5 2007 and July 30 2008 are planned to enroll in randomized into 2 groups from 10 centers: the experimental group and control group (1:1). The code-breaking time estimate is about June 2009. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. Main eligibility criteria were histologically or cytologically proven stage III or IV NSCLC, with an age of 18-75 years. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients with the curative effect reaches above SD or SD were randomized to receive endostar® plus TC or TC alone for 3 cycles. Each 21-day cycle consisted of endostar® 7.5mg/m2 on days 8 to days 21, carboplatin AUC 5 on day 1, and paclitaxel 175 mg/m on day 1. Primary endpoint: time to progression (TTP). Secondary endpoint:Progress Free Survival (PFS).1 year survival rate. objective response(OR), clinical benefit rate(CBR), median survival time (MST), quality of life (QOL) and remission rate of clinical symptom.

Eligibility Criteria

Inclusion Criteria:

histologically or cytologically proven stage III or IV NSCLC

age of 18-75 years

All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients with the curative effect reaches above SD or SD. without main organ functional disturbance

ECOG PS 0-2 with definite focus of infection(RECIST)

Exclusion Criteria:

brain metastases with Symptomatic

Severity Organ functional defect

backward heart failure

high risk arrhythmia with severity complication

pregnant woman and lactation female

Trial Contact Information

Trial Lead Organizations/Sponsors

Shandong Simcere Medgenn Bio-Pharmaceutical Company, Limited

Han baohui, Ph.D		Ph: 86-021-6282-1990
		Email: hbaohui@yahoo.com

Trial Sites

China

Shanghai

Shanghai Chest Hospital

Han baohui, Ph.D Ph: 86-021-6282-1990

Email: hbaohui@yahoo.com

Han baohui, Ph.D Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00708812
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.