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

Recurrent Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00168922
• Other study ID #: Haema CBF SCLC UK/AS 02
• Status: Recruiting
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: April 27, 2006
• Start date: February 2001
• Est. completion date: December 2006

Study information

• Verified date: January 2001
• Source: Charite University, Berlin, Germany
• Contact: Ulrich Keilholz, MD
• Phone: +49-30-8445-3596
• Email: ulrich.keilholz[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Recurrent Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Bendamustin/Ribomustin

Locations

Country	Name	City	State
Germany	Hematology & Oncology Charité CBF Berlin, Germany	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	ribosepharm GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of response rate ( CR + PR) after cytostatic therapy with Bendamustin 120mg/m2, day 1+2, repeat d 22
Primary	(primary goal)
Secondary	Assessment of toxicity, determination of time to progression, for median survival and one-year survival rate,investigation of life quality (secondary goal)