Spots Global Cancer Trial Database for Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
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Trial Identification
Brief Title: Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
Official Title: First International Randomized Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment
Study ID: NCT00094497
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable to complete surgical resection.
Detailed Description: The Firm-ACT trial is the first ever conducted randomized controlled phase III trial in adrenocortical carcinoma (ACC), a rare malignancy with poor prognosis. It will provide results leading to the establishment of an urgently needed gold standard chemotherapy regimen for patients with locally advanced or metastatic ACC. To this end the trial compares the two most promising drug combinations investigated in phase II trials, considered by the "International Consensus Conference on Adrenal Cancer" (Ann Arbor/USA, 2003) as valuable first line treatments for advanced ACC. The first regimen consists of etoposide, doxorubicin, cisplatin plus mitotane (EDP-M), the second regiment employs streptozotocin plus mitotane (Sz-M). Over a period of five years this international trial will include 300 patients with advanced ACC from different European countries. Blood mitotane concentrations will be monitored, aiming at drug levels between 14 - 20 mg/L. Patients not responding to the first line treatment will be switched to the alternative regimen. The primary objective of this trial is to investigate whether EDP-M given as first line treatment will prolong survival as compared to Sz-M. Secondary endpoints are quality of life, time to progression, best overall response rate and duration of response. In addition, the trial evaluates the role of reaching therapeutic mitotane serum concentrations for survival and tumour response and assesses the value of the two alternative treatment regimens as second line therapy in advanced ACC. Moreover, the FIRM-ACT trial will generate a lasting structural basis for successful future trials in ACC. In a substudy of 40 patients a detailed analysis of the pharmacokinetics of oral mitotane will be analysed. Two different mitotane treatment regimens ("low dose" vs. "high dose") will be compared.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Institute - Center for Cancer Research, Bethesda, Maryland, United States
University of Michigan, Department of Internal Medicine, Ann Arbor, Michigan, United States
Royal Adelaide Hospital, Adelaide, , Australia
University of Graz, Graz, , Austria
Clinique Marc Linquette, Lille, , France
Centre Leon Berard, Lyon, , France
Hospital de Marseille la timone, Marseille, , France
Cochin Hospital, Paris, , France
Hospital Bordeaux haut leveque, Pessac, , France
Institut Gustave Roussy, Villejuif, , France
Charité-University, Dept. of Endocrinology; Campus Benjamin Franklin, Berlin, , Germany
Charité-Universitätsmedizin Berlin - Campus Mitte, Berlin, , Germany
Dept. of Medicine III, Dresden, , Germany
University of Duesseldorf, Dept. of Endocrrinology, Duesseldorf, , Germany
Zentrum für Innere Medizin - Endokrinologie des Universitätsklinikum Essen, Essen, , Germany
Endokrinologie Medizinische Hochschule Hannover, Hannover, , Germany
Otto-von-Guericke University; Dept. of Endocrinology, Magdeburg, , Germany
Dept of Medicine I, Mainz, , Germany
University of Munich, Dept. of Internal Medicine (Innenstadt), Munich, , Germany
University of Wuerzburg - Dept. of Medicine, Wuerzburg, , Germany
University of Turin, Dept of Internal Medicine, Orbassano, , Italy
Clinica Endocrinologica, Università di Padova, Azienda Ospedaliera di Padova, Padova, , Italy
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Academisch Medisch Centrum; Dept. of Endocrinology, Amsterdam, , Netherlands
Maxima Medisch Centrum; Dept. of Internal Medicine, Eindhoven, , Netherlands
University Hospital Groningen; Dept. of Internal Medine, Groningen, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Department of Oncology, Sahlgrenska University Hospital, Gothenburg, , Sweden
Department of Oncology, Linköping University Hospital, Linköping, , Sweden
Department of Medicine, The Jubileum Institute, Lund University, Lund, , Sweden
Dept of Surgery, Karolinska Hospital, Stockholm, Stockholm, , Sweden
Uppsala University Hospital - Dept of Medical Sciences, Uppsala, , Sweden
Contact Details
Name: Britt Skogseid, MD
Affiliation: Uppsala University Hospital
Role: STUDY_CHAIR
Name: Martin Fassnacht, MD
Affiliation: University of Würzburg
Role: PRINCIPAL_INVESTIGATOR
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