NCT00168922

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

April 27, 2006

Status Verified

January 1, 2001

First QC Date

September 9, 2005

Last Update Submit

April 27, 2006

Conditions

Recurrent Small Cell Lung Cancer

Keywords

recurrent SCLC

Outcome Measures

Primary Outcomes (2)

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

  • (primary goal)

Secondary Outcomes (1)

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

Interventions

Bendamustin/RibomustinDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Brain metastases
  • WHO-PS 3 - 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology & Oncology Charité CBF Berlin, Germany

Berlin, State of Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ulrich Keilholz, MD

    Charité Campus Benjamin Franklin University Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrich Keilholz, MD

CONTACT

+49-30-8445-3596ulrich.keilholz@charite.de

Alexander Schmittel, MD

CONTACT

+49-30-8445-3090alexander.schmittel@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

February 1, 2001

Study Completion

December 1, 2006

Last Updated

April 27, 2006

Record last verified: 2001-01

Locations

DE(1)