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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2001 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Aventis Pharmaceuticals
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
First received: September 9, 2005
Last updated: February 13, 2006
Last verified: September 2001
Comparison of two combination chemotherapies in the treatment of patients with SLCL

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Primary Endpoint:
  • Documentation of the remission rate ( Phase II)
  • Determination of progress free time (Phase III)

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

Estimated Enrollment: 286
Study Start Date: October 2001
Estimated Study Completion Date: December 2006
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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  • chronic diarrhea, obstructive bowel syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168896

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

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
Aventis Pharmaceuticals
Principal Investigator: Ulrich Keilholz, MD Charité Campus Benjamin Franklin University Clinic
  More Information

ClinicalTrials.gov Identifier: NCT00168896     History of Changes
Other Study ID Numbers: Haema CBF SCLC UK/AS 01 
Study First Received: September 9, 2005
Last Updated: February 13, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

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

ClinicalTrials.gov processed this record on May 30, 2016