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

Launched by AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at whether adding progesterone to standard chemotherapy can help patients with advanced adrenocortical carcinoma (ACC), a rare type of cancer that affects the adrenal glands. The study is being conducted at ASST Spedali Civili Hospital and the University of Brescia in Italy, and it involves patients who have ACC that is too advanced for surgery. The trial is currently recruiting participants aged 18 and older who have been diagnosed with ACC and have a life expectancy of more than three months. Participants should also be able to manage everyday activities and meet certain health criteria.

If someone joins the trial, they will be randomly assigned to receive either the additional progesterone along with their usual chemotherapy or a placebo (a substance with no active treatment). This means that neither the participants nor their doctors will know which treatment they are getting, which helps keep the results unbiased. Participants will regularly check in with their healthcare team throughout the study to monitor their health and any side effects. It's important for potential participants to be aware that there are specific health conditions that could exclude them from the study, such as certain heart or kidney problems, recent cancer treatments, or being pregnant or breastfeeding.

Gender

ALL

Eligibility 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.
• 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.