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OpenTrials
Completed

NCT Number: NCT00708812

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

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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Key information

Conditions

Advanced Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200039, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endostar(Recombinant Human Endostatin Injection)

Drug

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

paclitaxel-carboplatin

Drug

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

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: every 2 months until disease progression

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: the end of each cycle

  2. Overall Survival (OS)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 2, 2008
Registry last updated
Jul 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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