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

NCT ID: NCT00168922

Last Updated: 2006-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Recurrent Small Cell Lung Cancer

Keywords

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recurrent SCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bendamustin/Ribomustin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ribosepharm GmbH

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Principal Investigators

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Ulrich Keilholz, MD

Role: PRINCIPAL_INVESTIGATOR

Charité Campus Benjamin Franklin University Clinic

Locations

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Hematology & Oncology Charité CBF Berlin, Germany

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ulrich Keilholz, MD

Role: CONTACT

Phone: +49-30-8445-3596

Email: [email protected]

Alexander Schmittel, MD

Role: CONTACT

Phone: +49-30-8445-3090

Email: [email protected]

Facility Contacts

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Ulrich Keilholz, MD

Role: primary

Alexander Schmittel, MD

Role: backup

Other Identifiers

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Haema CBF SCLC UK/AS 02

Identifier Type: -

Identifier Source: org_study_id