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
Verified date | February 2010 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ireland: Irish Medicines Board |
Study type | Interventional |
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).
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Austria, Belgium, Czech Republic, Egypt, France, Germany, Italy, Netherlands, Poland, Russian Federation, Spain, Switzerland, Taiwan,
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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