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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-12-31

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.

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Detailed Description

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Conditions

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Advanced Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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The control group

paclitaxel-carboplatin

Group Type ACTIVE_COMPARATOR

paclitaxel-carboplatin

Intervention Type DRUG

paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w

The treatment group

paclitaxel-carboplatin plus Endostar

Group Type EXPERIMENTAL

Endostar(Recombinant Human Endostatin Injection)

Intervention Type DRUG

Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle

paclitaxel-carboplatin

Intervention Type DRUG

paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w

Interventions

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Endostar(Recombinant Human Endostatin Injection)

Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle

Intervention Type DRUG

paclitaxel-carboplatin

paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No