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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2001 by Charite University, Berlin, Germany.
Recruitment status was Recruiting

Sponsor:

Collaborator:

ribosepharm GmbH

Information provided by:

Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT00168922

First received: September 9, 2005

Last updated: April 27, 2006

Last verified: January 2001

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

April 27, 2006

Start Date ^ICMJE

February 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00168922 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Recurrent Small Cell Lung Cancer

Intervention ^ICMJE

Drug: Bendamustin/Ribomustin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00168922

Other Study ID Numbers ^ICMJE

Haema CBF SCLC UK/AS 02

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

ribosepharm GmbH

Investigators ^ICMJE

Principal Investigator:

Ulrich Keilholz, MD

Charité Campus Benjamin Franklin University Clinic

Information Provided By

Charite University, Berlin, Germany

Verification Date

January 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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