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

Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143455
• Other study ID #: XRP4174D-3001
• 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

• Lung Neoplasms
• Small Cell Lung Carcinoma

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

External Links

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