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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Advanced Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Endostar(Recombinant Human Endostatin Injection)
* Drug: paclitaxel-carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small Cell Lung Cancer, Endostar, Paclitaxel, Carboplatin