Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma, Soft Tissue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bendamustin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Joerg T Hartmann, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Medical center II, University of Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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jth_002

Identifier Type: -

Identifier Source: org_study_id