Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

This study has been completed.
Sponsor:
Collaborators:
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204620
First received: September 13, 2005
Last updated: April 19, 2007
Last verified: April 2007

September 13, 2005
April 19, 2007
March 2002
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Complete list of historical versions of study NCT00204620 on ClinicalTrials.gov Archive Site
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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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma, Soft Tissue
Drug: Bendamustin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2006
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00204620
jth_002
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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