NCT00708812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 21, 2011

Status Verified

July 1, 2011

Enrollment Period

2.2 years

First QC Date

June 21, 2008

Last Update Submit

July 20, 2011

Conditions

Advanced Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung CancerEndostarPaclitaxelCarboplatin

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (PFS)

    every 2 months until disease progression

Secondary Outcomes (2)

  • Objective Response Rate (ORR)

    the end of each cycle

  • Overall Survival (OS)

    2 years

Study Arms (2)

The control group

ACTIVE COMPARATOR

paclitaxel-carboplatin

Drug: paclitaxel-carboplatin

The treatment group

EXPERIMENTAL

paclitaxel-carboplatin plus Endostar

Drug: Endostar(Recombinant Human Endostatin Injection)Drug: paclitaxel-carboplatin

Interventions

Endostar(Recombinant Human Endostatin Injection)DRUG

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

The treatment group
paclitaxel-carboplatinDRUG

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

The control groupThe treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • symptomatic brain metastases
  • bone metastases with complications
  • major organ dysfunction
  • bleeding diathesis or coagulopathy
  • pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200039, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CP protocol

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 21, 2008

First Posted

July 2, 2008

Study Start

July 1, 2007

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

July 21, 2011

Record last verified: 2011-07

Locations

CN(1)