Status:
COMPLETED
Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
Conditions:
Sarcoma, Soft Tissue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00204620
Start Date
March 1 2002
End Date
December 1 2006
Last Update
April 20 2007
Active Locations (1)
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1
Medical center II, University of Tuebingen
Tübingen, Germany