Phase II study on the combined systemic and intrathecal chemotherapy with methotrexate, ifosfamide and liposomal cytarabine (DepoCyte®) in patients with HER-2/neu-negative breast cancer and leptomeningeal spread - MTXIFODepocyte

• Conditions: HER-2/neu-negative breast cancer with leptomeningeal spread; MedDRA version: 12.0Level: LLTClassification code 10024233Term: Leptomeningeal metastases; MedDRA version: 12.0Level: LLTClassification code 10027475Term: Metastatic breast cancer

• Registration Number: EUCTR2009-014300-55-DE
• Lead Sponsor: Charité-Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-10
• Last Update Posted: 12 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• HER-2/neu-negative breast cancer
• leptomeningeal spread
• Distance from the last administration of cytostatic therapy of at least 3 weeks, except for the unique application of intrathecal methotrexate 15 mg within one week is allowed before enrollment.
• ECOG performance score =2
• no active infection
• age =18 years
• adequate renal function (Creatinine-Clearance >50 ml/min)
• adequate bone marrow reserve (peripheral granulocytes >1500/µl and thrombocytes >80000/µl)
• bilirubine up to 3 mg/dl, GOT <3 times the upper limit of normal (if liver metastases <5 times the upper limit of normal )
• negative pregnancy test and adequate contraception
• written informed consent
• availability and compliance

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

• breast cancer without leptomeningeal spread
• simultaneous participation in another clinical trial
• simultaneous or previous other malignant disease in the past 5 years
• treatment with salicylates, beta-lactam antibiotics or non-steroidal antirheumatic agents within one week before start of the MTX-containing treatment
• co-morbidities, appearing to make an intensive chemotherapy impossible
• large accumulation of extravascular fluid (e.g. pleural effusion, ascites)
• radio therapy of the skull or the whole cerebrospinal fluid space
• known intolerance to MTX, IFO, or DepoCyte®
• pregnant or breastfeeding women
• women of childbearing age without highly effective contraception (defined as Pearl-Index <1)

Study & Design

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