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RecruitingPhase 2NCT05913427

Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)

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)

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Enrollment

80 participants

Start Date

Jun 8, 2022

Study Type

INTERVENTIONAL

Conditions

Adrenocortical Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding progesterone to standard chemotherapy (EDP-M regimen) can improve treatment outcomes for people with adrenocortical carcinoma — a rare cancer of the adrenal gland. **You may be eligible if...** - You are 18 or older - You have confirmed adrenocortical carcinoma that cannot be surgically removed - Your cancer has spread or is locally advanced - You have good performance status (ECOG 0–2) - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have had prior chemotherapy for this cancer - You have a hormone-sensitive cancer (like certain breast or uterine cancers) that could be worsened by progesterone - You are pregnant or breastfeeding - You have severe organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtoposide, doxorubicin, cisplatin and Mitotane 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. Megestrol acetate will be prepared and packaged by the authorized external contract development and manufacturing organization (CDMO) Doppel Farmaceutici s.r.l. (Cortemaggiore, PC), that, according to the GMP and applicable law (FU XII ed) will also prepare the related placebo, in accordance with GMP (annex 13) and applicable law (FU XII ed.).

DRUGEtoposide, doxorubicin, cisplatin and Mitotane 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. Placebo 160 mg tablets will be developed by the CDMO to have the same appearance and taste as the tablet containing the active drug.

Locations(1)

Alfredo Berruti

Brescia, Italy

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NCT05913427

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