Randomised Phase II study with non-pegylated liposomal Doxorubicin (Myocet) plus Ifosfamid versus Doxorubicin plus Ifosfamid in the first-line treatment of locally advanced or metastatic soft tissue carcinoma. - LIDOXIF

• Conditions: Patients with locally advanced or metastatic soft tissue carcinoma and without any prior treatment are eligible for this study.

• Registration Number: EUCTR2006-003470-10-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-06
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
;
-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

-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 <3.0 x 109/L, platelets <80 x 109/L, bilirubin, SGOP,SGPT, AP >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

;
-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 <3.0 x 109/L, platelets <80 x 109/L, bilirubin, SGOP,SGPT, AP >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Cardiotoxicity ;Secondary Objective: Response Rate<br>General Toxicity<br>Overall Survival<br>Time to Progression<br>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<br>General Toxicity<br>Overall Survival<br>Time to Progression<br>Time to Remission;Primary end point(s): The primary endpoint is to evaluate the cardiotoxicity by ECG and LVEF.