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

Primary Purpose

Advanced Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostar(Recombinant Human Endostatin Injection)
paclitaxel-carboplatin
Sponsored by
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer, Endostar, Paclitaxel, Carboplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

The control group

The treatment group

Arm Description

paclitaxel-carboplatin

paclitaxel-carboplatin plus Endostar

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

Secondary Outcome Measures

Objective Response Rate (ORR)
Overall Survival (OS)

Full Information

First Posted
June 21, 2008
Last Updated
July 20, 2011
Sponsor
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00708812
Brief Title
Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-small Cell Lung Cancer
Keywords
Non-small Cell Lung Cancer, Endostar, Paclitaxel, Carboplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
Active Comparator
Arm Description
paclitaxel-carboplatin
Arm Title
The treatment group
Arm Type
Experimental
Arm Description
paclitaxel-carboplatin plus Endostar
Intervention Type
Drug
Intervention Name(s)
Endostar(Recombinant Human Endostatin Injection)
Intervention Description
Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
paclitaxel-carboplatin
Intervention Description
paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Time Frame
every 2 months until disease progression
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
the end of each cycle
Title
Overall Survival (OS)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200039
Country
China

12. IPD Sharing Statement

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

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