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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00168922
Enrollment
50
Registered
2005-09-15
Start date
2001-02-28
Completion date
2006-12-31
Last updated
2006-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Small Cell Lung Cancer

Keywords

recurrent SCLC

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

Interventions

DRUGBendamustin/Ribomustin

Sponsors

ribosepharm GmbH
CollaboratorUNKNOWN
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Assessment of toxicity, determination of time to progression, for median survival and one-year survival rate,investigation of life quality (secondary goal)—

Countries

Germany

Contacts

Primary ContactUlrich Keilholz, MD
ulrich.keilholz@charite.de+49-30-8445-3596
Backup ContactAlexander Schmittel, MD
alexander.schmittel@charite.de+49-30-8445-3090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026