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
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
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
NCT ID
NCT00708812
First Posted
June 21, 2008
Last Updated
July 20, 2011
Sponsor
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
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
Learn more about this trial
Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer
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