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

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NCT00143455

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Wels, , A-4600 Austria
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Small Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically or cytologically proven Small Cell Lung Cancer (SCLC)

- WHO performance status : 0, 1

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT00143455
Pfizer
Completed
Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer

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[email protected]

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Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small Cell Lung Carcinoma
  • Drug: Etoposide + cisplatin
    etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle
  • Drug: Irinotecan + cisplatin
    irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle
  • Experimental: B
    Intervention: Drug: Etoposide + cisplatin
  • Experimental: A
    Intervention: Drug: Irinotecan + cisplatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
485
December 2008
December 2008   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Czech Republic,   Egypt,   France,   Germany,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain,   Switzerland,   Taiwan
Ireland
 
NCT00143455
XRP4174D-3001
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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