A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.

NCT ID: NCT00700180

Last Updated: 2014-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-09-30

Brief Summary

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This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

7.5mg/kg iv on day 1 of each 3 week cycle

Carboplatin-based chemotherapy

Intervention Type DRUG

As prescribed

2

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

15mg/kg iv on day 1 of each 3 week cycle

Carboplatin-based chemotherapy

Intervention Type DRUG

As prescribed

Interventions

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bevacizumab [Avastin]

7.5mg/kg iv on day 1 of each 3 week cycle

Intervention Type DRUG

bevacizumab [Avastin]

15mg/kg iv on day 1 of each 3 week cycle

Intervention Type DRUG

Carboplatin-based chemotherapy

As prescribed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* locally advanced metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC);
* \>=1 measurable tumor lesion;
* ECOG performance status 0-1.

Exclusion Criteria

* prior chemotherapy or treatment with another systemic anti-cancer agent;
* evidence of CNS metastases;
* history of grade 2 or higher hemoptysis;
* evidence of tumor invading or abutting major blood vessels;
* malignancies other than NSCLC within 5 years prior to randomization, other than adequately treated cancer in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS;
* clinically significant cardiovascular disease;
* current or recent use of aspirin (\>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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St Leonards, New South Wales, Australia

Site Status

Adelaide, South Australia, Australia

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Adelaide, South Australia, Australia

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Box Hill, Victoria, Australia

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Fitzroy, Victoria, Australia

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Antwerp, , Belgium

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Liège, , Belgium

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Ostrava, , Czechia

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Prague, , Czechia

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Odense, , Denmark

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Paris, , France

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Rouen, , France

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Bad Berka, , Germany

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Großhansdorf, , Germany

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Hamburg, , Germany

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Oldenburg, , Germany

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Hong Kong, , Hong Kong

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Hong Kong, , Hong Kong

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Budapest, , Hungary

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Edelény, , Hungary

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Sopron, , Hungary

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Szombathely, , Hungary

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Törökbálint, , Hungary

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Milan, , Italy

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Milan, , Italy

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Orbassano, , Italy

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Roma, , Italy

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Enschede, , Netherlands

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Hoorn, , Netherlands

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Nieuwegein, , Netherlands

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Rotterdam, , Netherlands

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The Hague, , Netherlands

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Poznan, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Arkhangelsk, , Russia

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Chelyabinsk, , Russia

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Kazan', , Russia

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Kazan', , Russia

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Krasnodar, , Russia

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Krasnodar, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Seville, Sevilla, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Barakaldo, Vizcaya, Spain

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Changhua, , Taiwan

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Taichung, , Taiwan

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Taichung, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Aberdeen, , United Kingdom

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Chelmsford, , United Kingdom

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London, , United Kingdom

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Countries

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Australia Belgium Canada Czechia Denmark France Germany Hong Kong Hungary Italy Netherlands Poland Russia Spain Taiwan United Kingdom

Other Identifiers

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2008-000662-23

Identifier Type: -

Identifier Source: secondary_id

BO21015

Identifier Type: -

Identifier Source: org_study_id

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