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Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma

Phase 2
18 Years
Not Enrolling
Sarcoma, Soft Tissue

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Trial Information

Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Joerg T Hartmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

South West German Cancer Center, Medical Center II, University of Tuebingen


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

March 2002

Completion Date:

December 2006

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma