We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00204620
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 20, 2007
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
Information provided by:
University Hospital Tuebingen

September 13, 2005
September 20, 2005
April 20, 2007
March 2002
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00204620 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma
The aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd chemotherapy and to assess the treatment of toxicity.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sarcoma, Soft Tissue
Drug: Bendamustin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2006
Not Provided

Inclusion Criteria:

  • Histologically confirmed metastatic or non-resectable soft tissue sarcoma
  • Evidence of progression or relapse after an anthracycline-based and/ or ifosfamide-based chemotherapy
  • At least 1 bidimensionally measurable tumor lesion according to RECIST criteria
  • No previous radiation therapy on the only measurable lesion
  • Willingness to receive regular follow-up
  • Life expectancy more than 3 months
  • ECOG status >= 2
  • Patients aged 18 years and beyond
  • leucocytes > 2500/µl, thrombocytes > 75000/µl)
  • Serum creatine < 1,5 times the upper limit of normal value, GFR > 60/ml
  • Written patient informed consent
  • Ability to give informed consent

Exclusion Criteria:

  • Previous or concurrent radiation of the index lesion (radiation of single lesion is allowed if not the index lesion)
  • Insufficient liver function (bilirubin > 1.5 the upper limit of normal, prolongation of PT and aPTT > 1.5 the upper limit of normal; ASAT and ALAT > 3 the upper limit of normal (patients with liver metastases ASAT and ALAT > 5 the upper limit of normal)
  • Active infection
  • Prior therapy with Bendamustin hydrochloride
  • Prior malignancies (other than adequately treated carcinoma in situ (CIS) of the cervix, bladder urothelium, basal cell carcinoma or adenoma of the colon including pTIS,pTIN), unless treated with curative intent and without evidence of disease > 5 years
  • Symptomatic cardio- and/or cerebrovascular disease (NYHA-Scale III°)
  • Interval since last chemotherapy < 4 weeks
  • Evidence of CNS-metastases
  • Evidence of pregnancy or lactation
  • Woman of child-bearing potential without reliable methods of birth control
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
University Hospital Tuebingen
  • Arbeitsgemeinschaft fur Internistische Onkologie
  • German Sarcoma Group
Principal Investigator: Joerg T Hartmann, MD South West German Cancer Center, Medical Center II, University of Tuebingen
University Hospital Tuebingen
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP