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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Collaborative Group for Adrenocortical Carcinoma Treatment
• Collaborators: German Federal Ministry of Education and Research; National Cancer Institute (NCI)
• Treatments: Cisplatin; Doxorubicin; Etoposide; Liposomal doxorubicin; Mitotane; Streptozocin

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