Prospectively Randomized Phase I/II Trial of Liposomal-encapsulated Doxorubicin and Cisplatin +/- Locoregional Hyperthermia in patients with Metastatic Breast Cancer - Mammatherm

Klinikum der Universität München Innenstadt, I. Frauenklinik0 个研究点开始时间: 2007年8月17日最近更新: 2014年4月14日

适应症

试验速览

暂无简介。

•Patients may be included in the study only if they meet all the following criteria:
•- Documented metastatic disease other than bone metastases alone
•- Histopathological confirmed adenocarcinoma of the breast
•- At least one (2-dimensionally) measurable lesion according to RECIST criteria, applicable to locoregional hyperthermia, which is not intented to receive surgical or radiation therapy
•- Females ? 18 years of age
•- Performance Status =2 on ECOG-Scale
•- Estimated life expectancy of at least 12 weeks
•- Adequate bone marrow reserve: leucocytes ? 3.0 x 109/l and platelets ? 100,000 x 109/l
•- Serum creatinine level within 1.5 fold of the reference laboratory’s normal range
•SGOT, SGPT, ?-GT, Alkaline Phosphatase, Bilirubin, Albumin within 2.5 fold of the reference laboratory’s normal range
•- Left Ventricular Ejection Fraction (LVEF) >50% measured by bidimensional echocardiography
•- Intention of regular follow up visits for the duration of the study
•- Ability to understand the nature of the study and to give written informed consent
•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

•Patients will be excluded from the study for any of the following reasons:
•- For phase-II: More than 3 prior chemotherapy regimens including neo/adjuvant and palliative chemotherapy
•Note: For phase I, more than 3 prior chemotherapy regimens including neo/adjuvant and palliative chemotherapy are allowed
•- Prior anthracycline-containing regimens with more than cumulative dosage of
•oEpirubicin 600 mg/m2
•oDoxorubicin 300 mg/m2
•oMitoxantron 80 mg/m2
•- Resistance to anthracycline defined as relapse during or within 12 months after the - second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
•- Pregnancy or breast feeding (in premenopausal women anticonception has to be assured: Intrauterine devices, sterilisation or – only in hormone receptor negative women – oral or subcutaneous non estrogen containing contraception)
•- Disability to understand the nature of the study and give written consent

发起方

Klinikum der Universität München Innenstadt, I. Frauenklinik