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

Phase 2

• Conditions: Recurrent Small Cell Lung Cancer

• Registration Number: NCT00168922
• Lead Sponsor: Charite University, Berlin, Germany

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

Study Timeline

• Status Verified: 2001-01
• Study Start: 2001-02
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Last Update Submitted: 2006-04-27
• Last Update Posted: 2006-04-27
• Study Completion: 2006-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determination of response rate ( CR + PR) after cytostatic therapy with Bendamustin 120mg/m2, day 1+2, repeat d 22
(primary goal)

Secondary Outcome Measures

Name	Time	Method
Assessment of toxicity, determination of time to progression, for median survival and one-year survival rate,investigation of life quality (secondary goal)

Trial Locations

Locations (1)

Hematology & Oncology Charité CBF Berlin, Germany; 🇩🇪 Berlin, Germany