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
ribosepharm GmbH
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: September 9, 2005
Last updated: April 27, 2006
Last verified: January 2001
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

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

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
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 identifier: NCT00168922

Contact: Ulrich Keilholz, MD +49-30-8445-3596
Contact: Alexander Schmittel, MD +49-30-8445-3090

Hematology & Oncology Charité CBF Berlin, Germany Recruiting
Berlin, Germany, 12203
Contact: Ulrich Keilholz, MD    +49-30-8445-3596   
Contact: Alexander Schmittel, MD    +49-30-8445-3090   
Sponsors and Collaborators
Charite University, Berlin, Germany
ribosepharm GmbH
Principal Investigator: Ulrich Keilholz, MD Charité Campus Benjamin Franklin University Clinic
  More Information Identifier: NCT00168922     History of Changes
Other Study ID Numbers: Haema CBF SCLC UK/AS 02 
Study First Received: September 9, 2005
Last Updated: April 27, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
recurrent SCLC

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bendamustine Hydrochloride
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016