Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

NCT00204620 | Completed Phase 2

• 1 other identifier: jth_002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 the treatment of toxicity.

Conditions

Sarcoma, Soft Tissue

Interventions

Bendamustin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Arbeitsgemeinschaft fur Internistische Onkologie: collaborator
• German Sarcoma Group: collaborator

Study Sites (1)

Medical center II, University of Tuebingen

Tübingen, Germany

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joerg T Hartmann, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2002
• Study Completion: December 1, 2006
• Last Updated: April 20, 2007

Record last verified: 2007-04

Locations

DE (1)