ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00168922
Recruitment Status : Unknown
Verified January 2001 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : April 27, 2006
Sponsor:
Collaborator:
ribosepharm GmbH
Information provided by:
Charite University, Berlin, Germany

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

Condition or disease Intervention/treatment Phase
Recurrent Small Cell Lung Cancer Drug: Bendamustin/Ribomustin Phase 2

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 : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Determine the Efficacy of Bendamustin (Ribomustin) in Patients With Recurrent Small Cell Bronchial Carcinoma After Cytostatic Polychemotherapy
Study Start Date : February 2001
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. Assessment of toxicity, determination of time to progression, for median survival and one-year survival rate,investigation of life quality (secondary goal)


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00168922     History of Changes
Other Study ID Numbers: Haema CBF SCLC UK/AS 02
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 27, 2006
Last Verified: January 2001

Keywords provided by Charite University, Berlin, Germany:
recurrent 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
Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents