A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage - Full Text View

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

This study is currently recruiting participants.
Verified by Charite University, Berlin, Germany, September 2001

Sponsors and Collaborators:	Charite University, Berlin, Germany Pfizer Aventis Pharmaceuticals
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00168896

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 II Phase III

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Etoposide Carboplatin Irinotecan Irinotecan hydrochloride Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

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

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

Keywords provided by Charite University, Berlin, Germany:

SCLC

Study placed in the following topic categories:

Thoracic Neoplasms

Carcinoma, Neuroendocrine

Irinotecan

Carboplatin

Etoposide phosphate

Carcinoma

Neuroendocrine Tumors

Carcinoma, Small Cell

Neuroectodermal Tumors

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Adenocarcinoma

Etoposide

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Neoplasms, Nerve Tissue

Enzyme Inhibitors

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008