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

July 20, 2011 updated by: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200039
        • Shanghai Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The control group
paclitaxel-carboplatin
Drug: paclitaxel-carboplatin
paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w
Experimental: The treatment group
paclitaxel-carboplatin plus Endostar
Drug: paclitaxel-carboplatin
paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w
Drug: Endostar(Recombinant Human Endostatin Injection)
Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival (PFS)
Time Frame: every 2 months until disease progression
every 2 months until disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 2 years
2 years
Objective Response Rate (ORR)
Time Frame: the end of each cycle
the end of each cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 21, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (Estimate)

July 2, 2008

Study Record Updates

Last Update Posted (Estimate)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYL014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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