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. 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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sarcoma, Soft Tissue Drug: Bendamustin Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma
Study Start Date : March 2002
Actual Study Completion Date : December 2006

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00204620

Medical center II, University of Tuebingen
Tuebingen, Germany
Sponsors and Collaborators
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 Identifier: NCT00204620     History of Changes
Other Study ID Numbers: jth_002
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents