Prospectively Randomized Phase I/II Trial of Liposomal-encapsulated Doxorubicin and Cisplatin +/- Locoregional Hyperthermia in patients with Metastatic Breast Cancer - Mammatherm
- Conditions
- This is an open-label, multicenter, randomized controlled, Phase I/II study comparing the time to progressive disease after randomisation in patients treated with 6 cycles of liposomal-encapsulated Doxorubicin (Myocet®) and Cisplatin chemotherapy versus liposomal-encapsulated Doxorubicin and Cisplatin chemotherapy combined with locoregional hyperthermia.
- Registration Number
- EUCTR2005-005862-36-DE
- Lead Sponsor
- Klinikum der Universität München Innenstadt, I. Frauenklinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this study is to compare the time to progressive disease (TTPD) in a target volume amenable to locoregional hyperthermia in patients treated with liposomal-encapsulated Doxorubicin (Myocet®) and Cisplatin (MC) chemotherapy versus MC-chemotherapy combined with locoregional hyperthermia. <br>The definition of progressive disease will have to be verified by relevant methods of imaging diagnostics according to RECIST criteria.<br>;Secondary Objective: The secondary objectives of this study are to compare the following items in the two regimen arms:<br>•Response rate<br>•Survival time after randomisation<br>•Toxicity<br>•Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQ-BR23 questionnaire<br>;Primary end point(s): The primary endpoint of the study is to evaluate the tumor response rate.<br>The clinical response will be determinated using the RECIST criteria.<br>
- Secondary Outcome Measures
Name Time Method