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| Sponsors and Collaborators: |
Collaborative Group for Adrenocortical Carcinoma Treatment German Federal Ministry of Education and Research National Cancer Institute USA |
|---|---|
| Information provided by: | Collaborative Group for Adrenocortical Carcinoma Treatment |
| ClinicalTrials.gov Identifier: | NCT00094497 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Adrenal Cortical |
Drug: Etoposide Drug: Doxorubicin Drug: Cisplatin Drug: Streptozotocin Drug: Mitotane |
Phase III |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | First International Randomized Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment |
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Britt Skogseid, MD | +46 18 611 00 00 | Britt.skogseid@medsci.uu.se |
| Contact: Martin Fassnacht, MD | +49-931-201-0 ext 36788 | Fassnacht_m@medizin.uni-wuerzburg.de |
| United States, Maryland | |
| National Cancer Institute - Center for Cancer Research | Recruiting |
| Bethesda, Maryland, United States | |
| Contact: Maureen Edgerly +1-888-NCI-1937 edgerlym@mail.nih.gov | |
| United States, Michigan | |
| University of Michigan, Department of Internal Medicine | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Gary Hammer, MD 734-615-2421 ghammer@med.umich.edu | |
| Australia | |
| Royal Adelaide Hospital | Recruiting |
| Adelaide, Australia, SA 5000 | |
| Contact: David Torpy, MD +61 8 8222-5520 dtorpy@mail.rah.sa.gov.au | |
| Austria | |
| University of Graz | Recruiting |
| Graz, Austria, 8036 | |
| Contact: Vincent Stepan, MD +43- 316-385 82383 stepanvi@yahoo.com | |
| Principal Investigator: Vinzenz Stepan, MD | |
| France | |
| Cochin Hospital | Recruiting |
| Paris, France, 75679 | |
| Contact: Francois Goldwasser, MD francois.goldwasser@cch.ap-hop-paris.fr | |
| Clinique Marc Linquette | Recruiting |
| Lille, France | |
| Contact: J Wemeau, MD c-docao@chru-lille.fr | |
| Centre Leon Berard | Recruiting |
| Lyon, France | |
| Contact: Jean Piere Droz, MD droz@lyon.fnclcc.fr | |
| Contact: Quiblier, MD quiblier@lyon.fnclcc.fr | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, 94805 | |
| Contact: Eric Baudin, MD +33-142114242 baudin@igr.fr | |
| Hospital de Marseille la timone | Recruiting |
| Marseille, France, 13385 | |
| Contact: Patricia Niccoli Sire, MD patricia.niccoli-sire@mail.ap-hm.fr | |
| Hospital Bordeaux haut leveque | Recruiting |
| Pessac, France, 33600 | |
| Contact: Antoine Tabarin, MD antoine.tabarin@chu-bordeaux.fr | |
| Germany | |
| University of Wuerzburg - Dept. of Medicine | Recruiting |
| Wuerzburg, Germany, 97080 | |
| Contact: Bruno Allolio, MD +49-931-201-0 ext 36109 Allolio_b@medizin.uni-wuerzburg.de | |
| Contact: Martin Fassnacht, MD +49-931-201-0 ext 36788 Fassnacht_m@medizin.uni-wuerzburg.de | |
| University of Duesseldorf, Dept. of Endocrrinology | Recruiting |
| Duesseldorf, Germany, 40001 | |
| Contact: Matthias Schott, MD +49-211-811-7844 schottmt@uni-duesseldorf.de | |
| Charité-Universitätsmedizin Berlin - Campus Mitte | Recruiting |
| Berlin, Germany | |
| Contact: Marcus Quinckler, MD marcus.quinkler@charite.de | |
| Otto-von-Guericke University; Dept. of Endocrinology | Recruiting |
| Magdeburg, Germany, 39120 | |
| Contact: Hendrik Lehnert, MD + 49 391 67-15445 hendrik.lehnert@medizin.uni-magdeburg.de | |
| Charité-University, Dept. of Endocrinology; Campus Benjamin Franklin | Recruiting |
| Berlin, Germany | |
| Contact: Matthias Moehlig, MD +49-30-8445-646174 mmoehlig@mail.dife.de | |
| University of Munich, Dept. of Internal Medicine (Innenstadt) | Recruiting |
| Munich, Germany, 80336 | |
| Contact: Martin Reincke, MD +49-89-51602100 Martin.Reincke@med.uni-muenchen.de | |
| Zentrum für Innere Medizin - Endokrinologie des Universitätsklinikum Essen | Recruiting |
| Essen, Germany | |
| Contact: Stephan Petersenn, MD stephan.petersenn@uni-essen.de | |
| Endokrinologie Medizinische Hochschule Hannover | Recruiting |
| Hannover, Germany | |
| Contact: Georg Brabant, MD brabant.georg@mh-hannover.de | |
| Dept. of Medicine III | Recruiting |
| Dresden, Germany | |
| Contact: Stefan Bornstein, MD +49-351 458-5955 stefan.bornstein@uniklinikum-dresden.de | |
| Dept of Medicine I | Recruiting |
| Mainz, Germany | |
| Contact: Matthias M Weber, MD +40-6131-17-7255 MMWeber@uni-mainz.de | |
| Italy | |
| University of Turin, Dept of Internal Medicine | Recruiting |
| Orbassano, Italy, 10043 | |
| Contact: Massimo Terzolo, MD Terzolo@usa.net | |
| Contact: Alredo Berruti, MD alfredo.berruti@email.it | |
| Clinica Endocrinologica, Università di Padova, Azienda Ospedaliera di Padova | Recruiting |
| Padova, Italy | |
| Contact: Franco Mantero, Prof. 049-8213000 franco.mantero@unipd.it | |
| Netherlands | |
| Maxima Medisch Centrum; Dept. of Internal Medicine | Recruiting |
| Eindhoven, Netherlands, 5631 BM | |
| Contact: Harm Haak, MD +31-408885297 h.haak@mmc.nl | |
| Academisch Medisch Centrum; Dept. of Endocrinology | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Contact: Hans de Vries, MD +31 20566525 j.h.devries@amc.uva.nl | |
| Leiden University Medical Center | Recruiting |
| Leiden, Netherlands | |
| Contact: Hans Romijn, MD +31715263082 j.a.romijn@lumc.nl | |
| University Hospital Groningen; Dept. of Internal Medine | Recruiting |
| Groningen, Netherlands, 9700 | |
| Contact: Bruce Wolffenbuttel, MD +31 5036 13962 bwo@int.azg.nl | |
| Vrije Universiteit Medisch Centrum | Recruiting |
| Amsterdam, Netherlands, 1007 | |
| Contact: Mareliese Eekhoff, MD +31 204440588 EMW.Eekhoff@vumc.nl | |
| Sweden | |
| Uppsala University Hospital - Dept of Medical Sciences | Recruiting |
| Uppsala, Sweden, 751 85 | |
| Contact: Britt Skogseid, MD +46 18 611 00 00 Britt.Skogseid@medsci.uu.se | |
| Dept of Surgery, Karolinska Hospital, Stockholm | Recruiting |
| Stockholm, Sweden | |
| Contact: Goran Wallin, MD + 46 8 517 700 00 | |
| Department of Oncology, Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden | |
| Contact: Monica Sender, MD +46 31 3426626 monica.sender@vgregion.se | |
| Department of Oncology, Linköping University Hospital | Recruiting |
| Linköping, Sweden | |
| Contact: Najme Wall, MD +46 13 222000 najme.wall@lio.se | |
| Department of Medicine, The Jubileum Institute, Lund University | Recruiting |
| Lund, Sweden | |
| Contact: Michael Garkavij, MD +46 46 177520 michael.garkavij@onk.lu.se | |
| Study Chair: | Britt Skogseid, MD | Uppsala University Hospital |
More Information
| Study ID Numbers: | CO-ACT-001 |
| Study First Received: | October 19, 2004 |
| Last Updated: | November 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00094497 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Netherlands: Independent Ethics Committee; Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Adrenocortical Carcinoma Adrenocortical carcinoma Adrenal Gland Diseases Endocrine System Diseases Streptozocin Etoposide phosphate Mitotane Doxorubicin Carcinoma |
Adrenal Gland Neoplasms Cisplatin Adrenal Cortex Neoplasms Endocrinopathy Adenocarcinoma Adrenal Cortex Diseases Etoposide Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |
