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

History of Changes

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:

Genetics Home Reference related topics: lung cancer

Drug Information available for: Etoposide Carboplatin Irinotecan Irinotecan hydrochloride Etoposide phosphate

U.S. FDA Resources

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 (Adult, Senior)
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

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

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


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 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

ClinicalTrials.gov processed this record on September 28, 2016

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