Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

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

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 Overview

• Status: Completed
• Conditions: Sarcoma, Soft Tissue
• Intervention / Treatment: Drug: Bendamustin

• Study Type: Interventional
• Enrollment: 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany
    • Medical Center II, University of Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Arbeitsgemeinschaft fur Internistische Onkologie; German Sarcoma Group
• Investigators: Principal Investigator: Joerg T Hartmann, MD, South West German Cancer Center, Medical Center II, University of Tuebingen

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): April 20, 2007
• Last Update Submitted That Met QC Criteria: April 19, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Bendamustine Hydrochloride
• Other Study ID Numbers: jth_002