Study to Determine the Efficacy of Bendamustin in Patients With Recurrent Small Cell Lung Cancer (SCLC) - Full Text View

Study to Determine the Efficacy of Bendamustin in Patients With Recurrent Small Cell Lung Cancer (SCLC)

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

Sponsors and Collaborators:	Charite University, Berlin, Germany ribosepharm GmbH
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00168922

Purpose

Determination of response rate Assessment of toxicity and determination of "time to progression"

Condition	Intervention	Phase
Recurrent Small Cell Lung Cancer	Drug: Bendamustin/Ribomustin	Phase II

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Bendamustine Bendamustine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase II Study to Determine the Efficacy of Bendamustin (Ribomustin) in Patients With Recurrent Small Cell Bronchial Carcinoma After Cytostatic Polychemotherapy

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

Primary Outcome Measures:

Determination of response rate ( CR + PR) after cytostatic therapy with Bendamustin 120mg/m2, day 1+2, repeat d 22
(primary goal)

Secondary Outcome Measures:

Assessment of toxicity, determination of time to progression, for median survival and one-year survival rate,investigation of life quality (secondary goal)

Estimated Enrollment:	50
Study Start Date:	February 2001
Estimated Study Completion Date:	December 2006

Detailed Description:

Phase II Study to determine the efficacy of Bendamustin(Ribomustin) in patients with recurrent small cell bronchial carcinoma after cytostatic polychemotherapy

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with histological proven, curative non treatable small lung cell carcinoma
Recurrence >8 weeks, > 1 year after 1st line treatment with platin- and etoposide polychemotherapy, without brain metastases

Exclusion Criteria:

Brain metastases
WHO-PS 3 - 4

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168922

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

Sponsors and Collaborators

Charite University, Berlin, Germany

ribosepharm GmbH

Investigators


Principal Investigator:	Ulrich Keilholz, MD	Charité Campus Benjamin Franklin University Clinic

More Information

Study ID Numbers:	Haema CBF SCLC UK/AS 02
First Received:	September 9, 2005
Last Updated:	April 27, 2006
ClinicalTrials.gov Identifier:	NCT00168922
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

recurrent SCLC

Study placed in the following topic categories:

Thoracic Neoplasms

Carcinoma, Neuroendocrine

Recurrence

Carcinoma

Neuroendocrine Tumors

Carcinoma, Small Cell

Neuroectodermal Tumors

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Carcinoma, Bronchogenic

Adenocarcinoma

Bendamustine

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Disease Attributes

Neoplasms

Neoplasms by Histologic Type

Pathologic Processes

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Neoplasms, Nerve Tissue

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008