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
Phase 3
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Small Cell Lung Carcinoma
Both
Small Cell Lung Carcinoma
Trial Information
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
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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS) for the Full Analysis Population (FAP)
Outcome Time Frame:
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)
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Ireland: Irish Medicines Board
Study ID:
XRP4174D-3001
NCT ID:
NCT00143455
Start Date:
June 2002
Completion Date:
December 2008
Related Keywords:
- Small Cell Lung Carcinoma
- Carcinoma
- Lung Neoplasms
- Small Cell Lung Carcinoma
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