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
Sponsor:
Collaborators:
Pfizer
Aventis Pharmaceuticals
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00168896
First received: September 9, 2005
Last updated: February 13, 2006
Last verified: September 2001
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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:
SCLC

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide
Irinotecan
Etoposide phosphate
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014