Clinical trial NCT00143455: Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer
Official title: Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto (Registered)) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Overall Survival (OS) for the Full Analysis Population (FAP)
timeFrame: Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)
measure: Overall Survival for the Per Protocol (PP) Population
timeFrame: Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)
Secondary outcomes:
measure: Number of Subjects With Overall Confirmed Response
timeFrame: Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)
measure: Duration of Response (DR)
timeFrame: Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)
measure: Time to Tumor Progression (TTP)
timeFrame: Baseline to date of progression (every 9 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment until progression)
measure: European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)
timeFrame: Baseline, at every cycle (Day -1, Day 1 of cycle before treatment), at the end of the treatment, and every 2 months during follow-up
measure: Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics)
timeFrame: Every 3 weeks for up to 6 months on study treatment
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liège
country: Belgium
facility: Pfizer Investigational Site
city: Brno-Bohunice
country: Czech Republic
facility: Pfizer Investigational Site
city: Olomouc
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava - Poruba
country: Czech Republic
facility: Pfizer Investigational Site
city: Prague
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Usti Nad Labem
country: Czech Republic
facility: Pfizer Investigational Site
city: Alexandria
country: Egypt
facility: Pfizer Investigational Site
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Amiens Cedex 1
country: France
facility: Pfizer Investigational Site
city: Bobigny
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: Caen Cedex 05
country: France
facility: Pfizer Investigational Site
city: Limoges
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 9
country: France
facility: Pfizer Investigational Site
city: Meaux
country: France
facility: Pfizer Investigational Site
city: Mulhouse
country: France
facility: Pfizer Investigational Site
city: Pierre-Bénite
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Rouen Cedex 1
country: France
facility: Pfizer Investigational Site
city: Saint Brieuc
country: France
facility: Pfizer Investigational Site
city: Saint Etienne
country: France
facility: Pfizer Investigational Site
city: Saint Pierre
country: France
facility: Pfizer Investigational Site
city: Villefranche Sur Saone
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Bad Berka
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bovenden-Lenglern
country: Germany
facility: Pfizer Investigational Site
city: Ebensfeld
country: Germany
facility: Pfizer Investigational Site
city: Gauting
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Grosshansdorf
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Hemer
country: Germany
facility: Pfizer Investigational Site
city: Loewenstein
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Maastricht
country: Netherlands
facility: Pfizer Investigational Site
city: Nieuwegein
country: Netherlands
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Otwock
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Warsaw
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Moscow 115 478
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Aarau
country: Switzerland
facility: Pfizer Investigational Site
city: Basel
country: Switzerland
facility: Pfizer Investigational Site
city: Bellinzona
country: Switzerland
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Ch-4101 Bruderholz
country: Switzerland
facility: Pfizer Investigational Site
city: Thun
country: Switzerland
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyuan
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: