Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Adrenocortical Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05913427
- Run by
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- People needed
- 80
- Starts
- 2022-06-08
- Expected to finish
- 2027-06-08
- Last updated by the study team
- 2024-08-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Alfredo Berruti — Brescia, Italy (enrolling)
Full record on ClinicalTrials.gov
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