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

Sponsor
Pfizer
Study ID
NCT00143455
Phase
PHASE3
Status
Completed

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Jun 30, 2002
Status verified
Feb 2010
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

Enrollment
485 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: B
  • Experimental: A

Primary Outcome Measure

Overall Survival (OS) for the Full Analysis Population (FAP) [ 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) ]

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