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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
History of Changes
  Purpose

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 Intervention Phase
Sarcoma, Soft Tissue
 Drug: Bendamustin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Estimated Enrollment: 28
Study Start Date: March 2002
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204620

Locations
Germany
Medical center II, University of Tuebingen
Tuebingen, Germany
Sponsors and Collaborators
University Hospital Tuebingen
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
Investigators
Principal Investigator: Joerg T Hartmann, MD South West German Cancer Center, Medical Center II, University of Tuebingen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204620     History of Changes
Other Study ID Numbers: jth_002
Study First Received: September 13, 2005
Last Updated: April 19, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Bendamustine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013