advanced/ metastatic patients with ACC MedDRA version: 20.0 Level: PT Classification code 10001388 Term: Adrenocortical carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: MEGACE - 160 MG COMPRESSE 30 COMPRESSE
Product Name: megace
Product Code: [megace]
Pharmaceutical Form: Tablet
INN or Proposed INN: MEGESTROLO ACETATO
Current Sponsor code: megestrolo
Conc
Sponsors
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed diagnosis of ACC - Locally advanced or metastatic disease not amenable to radical surgery resection - ECOG performance status 0-2 - Effective contraception - Life expectancy > 3 months - Age > 18 years - Adequate bone marrow reserve (neutrophils >1,000/mm3 and/or platelets >80,000/mm3) and organ function (including renal, liver and cardiac function) - Be able to comply with the protocol procedures and provide 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years -Renal insufficiency (estimated glomerular filtration rate [GFR]2 times the upper normal range and/or serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST]>3 times the upper normal range). GFRs will be calculated according to the validated formula (MDRD) - Pregnancy or breast feeding - Congestive heart failure (ejection fraction<45%) -Preexisting grade 2 peripheral neuropathy - Previous or current treatment with mitotane or other antineoplastic drugs for ACC - Previous radiotherapy for ACC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity of the combination regimen (EDP-M plus progesterone (EDP-MP) versus EDP-M plus placebo) in advanced/ metastatic patients with ACC;Secondary Objective: To evaluate the impact of the combination of the two treatments on hormone response in patients with secreting ACC; To assess the activity of the combination regimen on disease response assessed by the CHOI criteria [15], and changes in Standardized Uptake Value (SUV) at FDG Positron Emission Tomography (PET) scan; - To compare the two treatment arms in terms of progression free survival (PFS); - To compare the two treatment arms in terms of overall survival (OS); - To evaluate the quality of life the quality of life by EORTC QLQ-C30; - To evaluate the toxicity of the regimen.;Primary end point(s): Evaluation of efficacy The following criteria will be used to assess treatment efficacy: - RECIST Criteria 1.1 (see table below); - Hormone response defined as 50% reduction of 24-h urinary free cortisol (UFC) excretion within 1 month of treatment; - CHOI Criteria (see table below); - SUV variation: PERCIST Criteria (see table below).;Timepoint(s) of evaluation of this end point: Week 4 8 12 16 20 24 28 End of treatment visit (28days after last chemotherapy cycle) Follow up visit (Every 12weeks for 1 year, t | — |
Countries
Italy
Contacts
Public ContactCOORDINAMENTO RICERCA E STUDI DI FA
ASST SPEDALI CIVILI DI BRESCIA
Outcome results
None listed