Adding progesterone to standard chemotherapy for advanced adrenocortical carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the efficacy of adding megestrol acetate, a form of progesterone, to the standard chemotherapy regimen of etoposide, doxorubicin, cisplatin, and Mitotane in patients with advanced adrenocortical carcinoma (ACC). The study is designed as a prospective randomized, double-blind, placebo-controlled trial, aiming to determine if the addition of progesterone can enhance the cytotoxic effects of the chemotherapy in ACC cells. Participants will be monitored for improvements in treatment efficacy and overall outcomes compared to those receiving a placebo.

Why it matters

Who can join: the full rules

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.

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 \[GFR\]\<50 mL/min/1.73 m2) or significant liver insufficiency (serum bilirubin\>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
* Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration or that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Where it's running

• Alfredo Berruti
  Brescia, Italy Recruiting

Study contacts

• Principal investigator: Alfredo Berruti — Asst Degli Spedali Civili Di Brescia
• Study coordinator: Aldo Roccaro
• Email: coordinamento.ricerca@asst-spedalicivili.it
• Phone: +390303996851

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.