First International Randomized trial in locally advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

Conditions: chemotherapy with etoposide, doxorubicin and cisplatin plus mitotane(EDP/M) as first line treatment versus streptozotocin plus mitotane (Sz/M) as firstline treatment in advanced and Metastatic Adrenocortical Carcinoma
MedDRA version: 8.1Level: LLTClassification code 10001388Term: Adrenocortical carcinoma

Registration Number: EUCTR2005-004137-18-AT

Lead Sponsor: Collaborative group for Adrenocortical Carcinoma Therapy (COAT)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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 verifiably afterwards.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 lace 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of etoposide, doxorubicin and cisplatin plus mitotane (EDP/M) as first line treatment versus streptozotocin plus mitotane (Sz/M) as first line treatment Study design Randomized, prospective, controlled,;Secondary Objective: quality of life<br>time to progression;Primary end point(s): Primary endpoint: to compare overall survival

Secondary Outcome Measures