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.
Conditions
Interventions
Trade Name: Myocet
Product Name: Myocet
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Lipsomenverkapselter Doxorubicin-Citrat-Komplex
Concentration unit: m
Sponsors
Klinikum der Universität München Innenstadt, I. Frauenklinik
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 o Epirubicin 600 mg/m2 o Doxorubicin 300 mg/m2 o Mitoxantron 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. The definition of progressive disease will have to be verified by relevant methods of imaging diagnostics according to RECIST criteria. ;Secondary Objective: The secondary objectives of this study are to compare the following items in the two regimen arms: • Response rate • Survival time after randomisation • Toxicity • Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQ-BR23 questionnaire ;Primary end point(s): The primary endpoint of the study is to evaluate the tumor response rate. The clinical response will be determinated using the RECIST criteria. | — |
Countries
Germany
Outcome results
None listed