Patients with locally advanced or metastatic soft tissue carcinoma and without any prior treatment are eligible for this study.
Conditions
Interventions
Trade Name: Myocet
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Doxorubicinhydrochlorid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Signed written informed consent -Male or female > 18 years of age -Histologically confirmed locally advanced or metastatic soft tissue carcinoma -At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT or > 20 mm with conventional CT) must be present -if of childbearing potential, willingness to use effective contraceptive methods and negative pregnancy -male participants have to use effective contraceptive methods Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: -Signed written informed consent -Male or female > 18 years of age -Histologically confirmed locally advanced or metastatic soft tissue carcinoma -At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT or > 20 mm with conventional CT) must be present -if of childbearing potential, willingness to use effective contraceptive methods and negative pregnancy -male participants have to use effective contraceptive methods Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Other serious illness or medical conditions, Pregnancy or breast-feeding -Unstable cardiac disease despite treatment, -congestive heart failure NYHA grade 3 and 4; acute MI -cystitis -increased tendency to bleed -known hypersensivity against ifosfamide or anthacylines -pretreatment with anthracyclines up to the cumulative maximum dose -missing written informed consent -Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; -Having participated in another clinical trial or having received any investigational agent in the preceding 30 days -Known allergic/hypersensitivity reaction to any of the components of the treatment -Pregnancy (absence confirmed by serum/urine b-HCG) or breast-feeding -Other active malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix -Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent -Lab results: leucocytes 2x of the upper limit, creatinine > 1,5 mg/dl -persons who are detained officially or legally to an official institute - ECOG >2 -life-expectancy 2x of the upper limit, creatinine > 1,5 mg/dl -persons who are detained officially or legally to an official institute - ECOG >2 -life-expectancy < 3month -any chemotherapeutic treatment before participating in the CT -histology: GIST, neurofibrosarcomas, fibrosarcomas, chondrosarcomas, highly differentiated sarcomas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cardiotoxicity ;Secondary Objective: Response Rate General Toxicity Overall Survival Time to Progression Time to Remission;Primary end point(s): The primary endpoint is to evaluate the cardiotoxicity by ECG and LVEF. ;Main Objective: Cardiotoxicity ;Secondary Objective: Response Rate General Toxicity Overall Survival Time to Progression Time to Remission;Primary end point(s): The primary endpoint is to evaluate the cardiotoxicity by ECG and LVEF. | — |
Countries
Germany
Contacts
Public Contact; ;
;
Outcome results
None listed