Trial | NCT00204620  Report issue

Title

Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    28
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.
Study Started
Mar 31
2002
Study Completion
Dec 31
2006
Last Update
Apr 20
2007
Estimate

Drug Bendamustin

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
No Results Posted