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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Recurrent Small Cell Lung Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Ulrich Keilholz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Campus Benjamin Franklin University Clinic

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Haema CBF SCLC UK/AS 02

NCT ID:

NCT00168922

Start Date:

February 2001

Completion Date:

December 2006

Related Keywords:

  • Recurrent Small Cell Lung Cancer
  • recurrent SCLC
  • Carcinoma, Bronchogenic
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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