Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
Carcinoma, Adrenal Cortical
About this trial
This is an interventional treatment trial for Carcinoma, Adrenal Cortical
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of adrenocortical carcinoma Locally advanced or metastatic disease not amenable to radical surgery resection (Stage III-IV) Radiologically monitorable disease ECOG performance status 0-2 Life expectancy > 3 months Age ≥18 years Adequate bone marrow reserve (neutrophils > 1500/mm3 and platelets > 100,000/mm3) Effective contraception in pre-menopausal female and male patients Patient's written informed consent Ability to comply with the protocol procedures (including availability for follow-up visits) Previous palliative surgery, radiotherapy or radiofrequency ablation is acceptable as long as radiologically monitorable disease is verifiable afterwards. Exclusion Criteria: History of prior malignancy, except for cured non-melanoma skin cancer, curatively in situ cervical carcinoma, or other cancers treated with no evidence of disease for at least five years. Previous cytotoxic chemotherapy for adrenocortical carcinoma Renal insufficiency (serum creatinine ≥2 mg/dl or creatinine clearance ≤ 50 ml/min) Hepatic insufficiency (serum bilirubin ≥2 x the institutional upper limit of normal range and/or serum transaminases ≥ 3 x the institutional upper limit of normal range; exception: in patients on mitotane, transaminase levels up to 5 x the institutional upper limit of normal range are acceptable) Pregnancy or breast feeding Known hypersensitivity to any drug included in the treatment protocol Presence of active infection Any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion Decompensated heart failure (ejection fraction <50%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, and uncontrolled cardiac arrhythmia Current treatment with other experimental drugs and/or previous participation in clinical trials with other experimental agents for adrenocortical carcinoma Prisoners
Sites / Locations
- National Cancer Institute - Center for Cancer Research
- University of Michigan, Department of Internal Medicine
- Royal Adelaide Hospital
- University of Graz
- Clinique Marc Linquette
- Centre Leon Berard
- Hospital de Marseille la timone
- Cochin Hospital
- Hospital Bordeaux haut leveque
- Institut Gustave Roussy
- Charité-University, Dept. of Endocrinology; Campus Benjamin Franklin
- Charité-Universitätsmedizin Berlin - Campus Mitte
- Dept. of Medicine III
- University of Duesseldorf, Dept. of Endocrrinology
- Zentrum für Innere Medizin - Endokrinologie des Universitätsklinikum Essen
- Endokrinologie Medizinische Hochschule Hannover
- Otto-von-Guericke University; Dept. of Endocrinology
- Dept of Medicine I
- University of Munich, Dept. of Internal Medicine (Innenstadt)
- University of Wuerzburg - Dept. of Medicine
- University of Turin, Dept of Internal Medicine
- Clinica Endocrinologica, Università di Padova, Azienda Ospedaliera di Padova
- Vrije Universiteit Medisch Centrum
- Academisch Medisch Centrum; Dept. of Endocrinology
- Maxima Medisch Centrum; Dept. of Internal Medicine
- University Hospital Groningen; Dept. of Internal Medine
- Leiden University Medical Center
- Department of Oncology, Sahlgrenska University Hospital
- Department of Oncology, Linköping University Hospital
- Department of Medicine, The Jubileum Institute, Lund University
- Dept of Surgery, Karolinska Hospital, Stockholm
- Uppsala University Hospital - Dept of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
EDP-M
Sz-M
etopodide, doxorubicin, cisplatin and mitotane
streptozotocin and mitotane