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A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

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ClinicalTrials.gov Identifier: NCT00168896
Recruitment Status : Unknown
Verified September 2001 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : February 14, 2006
Sponsor:
Collaborators:
Pfizer
Aventis Pharmaceuticals
Information provided by:
Charite University, Berlin, Germany

Study Description
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Brief Summary:
Comparison of two combination chemotherapies in the treatment of patients with SLCL

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Carboplatin plus Irinotecan vs Carboplatin plus Etoposide Phase 2 Phase 3

Detailed Description:

Comparison of two combination chemotherapies in the treatment of patients with SLCL

The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage
Study Start Date : October 2001
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Primary Endpoint:
  2. Documentation of the remission rate ( Phase II)
  3. Determination of progress free time (Phase III)

Secondary Outcome Measures :
  1. Secondary Endpoint:
  2. Documentation of progress free time (Phase II)
  3. Documentation of objective remission rate ( Phase III)
  4. Documentation of 1-year survival rate
  5. Documentation of safety of the drug combination

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cytological or histological proven SCLC Stage I or II at 1st diagnosis
  • no prior chemotherapy
  • measurable tumor disease
  • karnofsky performance 70

Exclusion Criteria:

  • second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
  • NYHA III
  • chronic diarrhea, obstructive bowel syndrome
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168896


Contacts
Contact: Ulrich Keilholz, MD +49-30-8445-3596 ulrich.keilholz@charite.de
Contact: Alexander Schmittel, MD +49-30-8445-3090 alexander.schmittel @charite.de

Locations
Germany
Hematology & Oncology Charité CBF Berlin, Germany Recruiting
Berlin, Germany, 12203
Contact: Ulrich Keilholz, MD    +49-30-8445-3596    ulrich.keilholz@charite.de   
Contact: Alexander Schmittel, MD    +49-30-8445-3090    alexander.schmittel@charite.de   
Principal Investigator: Ulrich Keilholz, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Pfizer
Aventis Pharmaceuticals
Investigators
Principal Investigator: Ulrich Keilholz, MD Charité Campus Benjamin Franklin University Clinic
More Information
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ClinicalTrials.gov Identifier: NCT00168896     History of Changes
Other Study ID Numbers: Haema CBF SCLC UK/AS 01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 14, 2006
Last Verified: September 2001

Keywords provided by Charite University, Berlin, Germany:
SCLC

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
 Etoposide phosphate
Carboplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors