Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer

NCT ID: NCT00143455

Last Updated: 2010-02-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2008-12-31

Brief Summary

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To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).

Detailed Description

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Conditions

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Small Cell Lung Carcinoma

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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B

Group Type EXPERIMENTAL

Etoposide + cisplatin

Intervention Type DRUG

etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle

A

Group Type EXPERIMENTAL

Irinotecan + cisplatin

Intervention Type DRUG

irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle

Interventions

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Etoposide + cisplatin

etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle

Intervention Type DRUG

Irinotecan + cisplatin

irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven Small Cell Lung Cancer (SCLC)
* WHO performance status : 0, 1

Exclusion Criteria

* No previous radiotherapy is allowed except on bone metastases when newly diagnosed. Radiotherapy is not allowed for vena cava syndrome, a stent is recommended ;
* No prior surgery on the primary tumor except for palliative purpose (stent for vena cava syndrome).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Wels, , Austria

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Brno-Bohunice, , Czechia

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Olomouc, , Czechia

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Ostrava - Poruba, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Ústí nad Labem, , Czechia

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Alexandria, , Egypt

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Cairo, , Egypt

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Amiens, , France

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Bobigny, , France

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Bordeaux, , France

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Brest, , France

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Caen, , France

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Limoges, , France

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Marseille, , France

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Meaux, , France

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Mulhouse, , France

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Pierre-Bénite, , France

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Rennes, , France

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Rouen, , France

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Saint-Brieuc, , France

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Saint-Etienne, , France

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Saint-Pierre, , France

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Villefranche-sur-Saône, , France

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Villejuif, , France

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Bad Berka, , Germany

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Berlin, , Germany

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Bovenden-Lenglern, , Germany

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Ebensfeld, , Germany

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Gauting, , Germany

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Göttingen, , Germany

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Großhansdorf, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Hemer, , Germany

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Löwenstein, , Germany

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München, , Germany

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Bologna, , Italy

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Perugia, , Italy

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Amsterdam, , Netherlands

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Breda, , Netherlands

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Groningen, , Netherlands

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Maastricht, , Netherlands

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Nieuwegein, , Netherlands

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Lodz, , Poland

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Otwock, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Moscow, , Russia

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Moscow 115 478, , Russia

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Saint Petersburg, , Russia

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Barcelona, BARCELONA, Spain

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Madrid, Madrid, Spain

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Aarau, , Switzerland

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Basel, , Switzerland

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Bellinzona, , Switzerland

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Bern, , Switzerland

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Ch-4101 Bruderholz, , Switzerland

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Thun, , Switzerland

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Countries

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Austria Belgium Czechia Egypt France Germany Italy Netherlands Poland Russia Spain Switzerland Taiwan

Related Links

Other Identifiers

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XRP4174D-3001

Identifier Type: -

Identifier Source: org_study_id

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