Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

Completed · Phase 3

Conditions studied: Carcinoma, Adrenal Cortical

In brief

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.

Key facts

Study ID

NCT00094497

Run by

Collaborative Group for Adrenocortical Carcinoma Treatment

People needed

304

Starts

2004-06-01

Expected to finish

2010-12-01

Last updated by the study team

2016-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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 — Düsseldorf, Germany
• Zentrum für Innere Medizin - Endokrinologie des Universitätsklinikum Essen — Essen, Germany
• Endokrinologie Medizinische Hochschule Hannover — Hanover, 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 — Würzburg, 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

Full record on ClinicalTrials.gov

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