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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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 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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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 ClinicalTrials.gov identifier: NCT00168922

Locations
Germany
Hematology & Oncology Charité CBF Berlin, Germany
Berlin, Germany, 12203
Sponsors and Collaborators
Charite University, Berlin, Germany
ribosepharm GmbH
Investigators
Principal Investigator: Ulrich Keilholz, MD Charité Campus Benjamin Franklin University Clinic
  More Information

ClinicalTrials.gov 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:
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

ClinicalTrials.gov processed this record on December 07, 2016