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Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)

NCT ID: NCT01368848

Last Updated: 2013-08-30

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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

Brief Summary

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Despite recent advances in the treatment of NSCLC overall survival within these patients remains dismal and there is yet an unmet medical need for additional treatment options. In this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and bevacizumab) is tested to determine the objective response rate in patients with unresectable and advanced non-small cell lung cancer. This response rate will be compared with historical data.

Detailed Description

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Conditions

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NSCLC

Keywords

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AGMT NSCLC non-small cell lung cancer bevacizumab Avastin Cisplatin Docetaxel Taxotere Inoperable stages IIIB and IV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bevacizumab

3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -\> Staging

-\> further 3 cycles BCD Q3W -\> Bevacizumab Q3W until progression

Intervention Type DRUG

Cisplatin

3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -\> Staging

-\> further 3 cycles BCD Q3W

Intervention Type DRUG

Docetaxel

3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -\> Staging

-\> further 3 cycles BCD Q3W

Intervention Type DRUG

Other Intervention Names

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Avastin Taxotere

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically documented inoperable, locally advanced, metastatic or recurrent NSCLC other than squamous cell
* At least 1 measurable lesion according to RECIST criteria
* ECOG performance score 0 or 1
* Age between 18 and 70 years

Exclusion Criteria

* Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
* History of haemoptysis
* Evidence of tumour invading major blood vessels on imaging.
* Previous neoadjuvant/adjuvant chemotherapy.
* Previous radiotherapy.
* Serious uncontrolled coagulation disorder or thrombo-embolic complications within 6 months prior to study start or history of serious bleeding complications.
* Major surgical procedures within 4 weeks prior to study entry.
* Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
* Non-healing wound, active peptic ulcer or bone fracture.
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III

Salzburg, Salzburg, Austria

Site Status

Univ.-Klinik für Innere Medizin V Innsbruck, Abteilung für Hämatologie und Onkologie

Innsbruck, Tyrol, Austria

Site Status

Landeskrankenhaus Feldkirch

Feldkirch, Vorarlberg, Austria

Site Status

Countries

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Austria

Other Identifiers

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2008-000765-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AGMT_NSCLC 1

Identifier Type: -

Identifier Source: org_study_id