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

NCT00143455

Last updated date
Study Location
Pfizer Investigational Site
Wels, , A-4600, Austria
Contact
1-800-718-1021

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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).

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Small Cell Lung CarcinomaStudy Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer NCT00143455
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  3. Leuven,
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  27. Saint Pierre,
  28. Villefranche Sur Saone,
  29. Villejuif,
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  36. Grosshansdorf,
  37. Hamburg,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: B
    Intervention: Drug: Etoposide + cisplatin
  • Experimental: A
    Intervention: Drug: Irinotecan + cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2009)
485
Original Enrollment  ICMJE
 (submitted: September 1, 2005)
404
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Czech Republic,   Egypt,   France,   Germany,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain,   Switzerland,   Taiwan
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT00143455
Other Study ID Numbers  ICMJE XRP4174D-3001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP