Prospective, Phase II Study to Evaluate the Efficacy of Addition of Progesterone to Standard Chemotherapy According to Etoposide-Doxorubicin-Cisplatin Scheme Plus Mitotane (EDP-M) in Patients With Advanced Adrenocortical Carcinoma (ACC)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a prospective randomized, double blind, placebo controlled phase II study planned in patients with advanced ACC. The study will be conducted at ASST Spedali Civili Hospital and University of Brescia in Brescia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Alfredo Berruti
RECRUITING
Brescia
Contact Information
Primary
Aldo Roccaro
coordinamento.ricerca@asst-spedalicivili.it
+390303996851
Time Frame
Start Date: 2022-06-08
Estimated Completion Date: 2027-06-08
Participants
Target number of participants: 80
Treatments
Experimental: EDP-M plus MEGESTROL ACETATE 160 mg
EDP will be administered at the following doses: doxorubicin 40 mg/m2 on day 1, etoposide 100 mg/m2 days 2-4, cisplatin 40 mg/m2 days 3-4, every 28 days. Concomitant mitotane therapy will be administered continuously. Megestrole 160 mg 2 tablets will be administered once daily (in the morning) and will be stopped 21 days after the last administration of the EDP.
Placebo_comparator: EDP-M plus PLACEBO
EDP will be administered at the following doses: doxorubicin 40 mg/m2 on day 1, etoposide 100 mg/m2 days 2-4, cisplatin 40 mg/m2 days 3-4, every 28 days. Concomitant mitotane therapy will be administered continuously. Placebo 2 tablets will be administered once daily (in the morning) and will be stopped 21 days after the last administration of the EDP.
Related Therapeutic Areas
Sponsors
Leads: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia