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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00143455
Other study ID # XRP4174D-3001
Secondary ID
Status Completed
Phase Phase 3
First received September 1, 2005
Last updated February 10, 2010
Start date June 2002
Est. completion date December 2008

Study information

Verified date February 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Ireland: Irish Medicines Board
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 485
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Etoposide + cisplatin
etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle
Irinotecan + cisplatin
irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle

Locations

Country Name City State
Austria Pfizer Investigational Site Wels
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Leuven
Belgium Pfizer Investigational Site Liège
Czech Republic Pfizer Investigational Site Brno-Bohunice
Czech Republic Pfizer Investigational Site Olomouc
Czech Republic Pfizer Investigational Site Ostrava - Poruba
Czech Republic Pfizer Investigational Site Prague
Czech Republic Pfizer Investigational Site Praha 8
Czech Republic Pfizer Investigational Site Usti Nad Labem
Egypt Pfizer Investigational Site Alexandria
Egypt Pfizer Investigational Site Cairo
France Pfizer Investigational Site Amiens Cedex 1
France Pfizer Investigational Site Bobigny
France Pfizer Investigational Site Bordeaux
France Pfizer Investigational Site Brest
France Pfizer Investigational Site Caen Cedex 05
France Pfizer Investigational Site Limoges
France Pfizer Investigational Site Marseille Cedex 9
France Pfizer Investigational Site Meaux
France Pfizer Investigational Site Mulhouse
France Pfizer Investigational Site Pierre-Bénite
France Pfizer Investigational Site Rennes
France Pfizer Investigational Site Rouen Cedex 1
France Pfizer Investigational Site Saint Brieuc
France Pfizer Investigational Site Saint Etienne
France Pfizer Investigational Site Saint Pierre
France Pfizer Investigational Site Villefranche Sur Saone
France Pfizer Investigational Site Villejuif
Germany Pfizer Investigational Site Bad Berka
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Bovenden-Lenglern
Germany Pfizer Investigational Site Ebensfeld
Germany Pfizer Investigational Site Gauting
Germany Pfizer Investigational Site Goettingen
Germany Pfizer Investigational Site Grosshansdorf
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Heidelberg
Germany Pfizer Investigational Site Hemer
Germany Pfizer Investigational Site Loewenstein
Germany Pfizer Investigational Site Muenchen
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Perugia
Netherlands Pfizer Investigational Site Amsterdam
Netherlands Pfizer Investigational Site Breda
Netherlands Pfizer Investigational Site Groningen
Netherlands Pfizer Investigational Site Maastricht
Netherlands Pfizer Investigational Site Nieuwegein
Poland Pfizer Investigational Site Lodz
Poland Pfizer Investigational Site Otwock
Poland Pfizer Investigational Site Poznan
Poland Pfizer Investigational Site Warsaw
Poland Pfizer Investigational Site Warszawa
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow 115 478
Russian Federation Pfizer Investigational Site St. Petersburg
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Switzerland Pfizer Investigational Site Aarau
Switzerland Pfizer Investigational Site Basel
Switzerland Pfizer Investigational Site Bellinzona
Switzerland Pfizer Investigational Site Bern
Switzerland Pfizer Investigational Site Ch-4101 Bruderholz
Switzerland Pfizer Investigational Site Thun
Taiwan Pfizer Investigational Site Taichung
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Egypt,  France,  Germany,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  Switzerland,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) for the Full Analysis Population (FAP) 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) No
Primary Overall Survival for the Per Protocol (PP) Population 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) No
Secondary Number of Subjects With Overall Confirmed Response 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) No
Secondary Duration of Response (DR) 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) No
Secondary Time to Tumor Progression (TTP) 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) No
Secondary European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) 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 No
Secondary Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics) Every 3 weeks for up to 6 months on study treatment No
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