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Lung (Small Cell)

Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer

Unique Dataset IDLungSm_Pfizer_2002_419ClinicalTrial.gov IDNCT00143455
DownloadableYes
SponsorPfizerData ProviderPfizerTotal Study Enrolled Patients485Comparator (Control) Arm Enrolled Patients243RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, DrugDataset TypeADS

Clinical Trial Title

Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer

Trial Summary and Conditions

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).

Data Summary

Raw and Analysis datasets in both CSV and SAS7BDAT formats for Cohort 1 and for Cohort 2.

Study Objectives

PRIMARY: 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 ED-SCLC; SECONDARY: 1. To compare the overall response rate, the duration of response and the time to progression between the two treatment regimens, 2. To compare the safety of the two treatment regimens, 3. To compare the quality of life of patients treated with the two regimens, utilizing the EORTC quality of life scale, 4. To compare the tumor-related symptoms (pain, dyspnea and the use of opioids and non-opioids analgesics).

Outcome Measures

PRIMARY: 1. Overall Survival (OS) for the Full Analysis Population (FAP), 2. Overall Survival for the Per Protocol (PP) Population; SECONDARY: 1. Number of Subjects With Overall Confirmed Response; 2. Duration of Response (DR), 3. Time to Tumor Progression (TTP), 4. European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30), 5. Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics).

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: XRP4174D-3001 Protocol Amendment 5 15 December 2004_Redacted.pdf

CRF: NCT00143455_CRF_README.docx

DATA DICTIONARY: NCT00143455_DD_README.docx

DATA (COMPARATOR ARM): XRP4174D-3001_cohort1_CSVfiles.zip

DATA (COMPARATOR ARM): XRP4174D-3001_cohort1_SAS7BDATfiles.zip

DATA (COMPARATOR ARM): XRP4174D-3001_cohort2_CSVfiles.zip

DATA (COMPARATOR ARM): XRP4174D-3001_cohort2_SAS7BDATfiles.zip