Back to resultsStudy to Determine the Efficacy of Bendamustin in Patients With Recurrent Small Cell Lung Cancer (SCLC)
Primary Purpose
Recurrent Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Bendamustin/Ribomustin
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Small Cell Lung Cancer focused on measuring recurrent SCLC
Eligibility 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
Sites / Locations
- Hematology & Oncology Charité CBF Berlin, GermanyRecruiting
Outcomes
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)
Full Information
NCT ID
NCT00168922
First Posted
September 9, 2005
Last Updated
April 27, 2006
Sponsor
Charite University, Berlin, Germany
Collaborators
ribosepharm GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00168922
Brief Title
Study to Determine the Efficacy of Bendamustin in Patients With Recurrent Small Cell Lung Cancer (SCLC)
Official Title
Phase II Study to Determine the Efficacy of Bendamustin (Ribomustin) in Patients With Recurrent Small Cell Bronchial Carcinoma After Cytostatic Polychemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Unknown status
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
ribosepharm GmbH
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Small Cell Lung Cancer
Keywords
recurrent SCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bendamustin/Ribomustin
Primary Outcome Measure Information:
Title
Determination of response rate ( CR + PR) after cytostatic therapy with Bendamustin 120mg/m2, day 1+2, repeat d 22
Title
(primary goal)
Secondary Outcome Measure Information:
Title
Assessment of toxicity, determination of time to progression, for median survival and one-year survival rate,investigation of life quality (secondary goal)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrich Keilholz, MD
Phone
+49-30-8445-3596
Email
ulrich.keilholz@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Schmittel, MD
Phone
+49-30-8445-3090
Email
alexander.schmittel@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Organizational Affiliation
Charité Campus Benjamin Franklin University Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology & Oncology Charité CBF Berlin, Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Phone
+49-30-8445-3596
Email
ulrich.keilholz@charite.de
First Name & Middle Initial & Last Name & Degree
Alexander Schmittel, MD
Phone
+49-30-8445-3090
Email
alexander.schmittel@charite.de
12. IPD Sharing Statement
Learn more about this trial
Study to Determine the Efficacy of Bendamustin in Patients With Recurrent Small Cell Lung Cancer (SCLC)
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