Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

Sarcoma, Soft Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204620
• Other study ID #: jth_002
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 19, 2007
• Start date: March 2002
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Soft Tissue

Intervention

Drug:
• Bendamustin

Locations

Country	Name	City	State
Germany	Medical center II, University of Tuebingen	Tuebingen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group

Country where clinical trial is conducted

Germany,