Adrenocortical Carcinoma Cancer Adrenocortical carcinoma
Conditions
Interventions
Etoposide, Doxorubicin, Cisplatin plus Mitotane (EDP/M) or Streptozotocin plus Mitotane (Sz/M) as first line treatment.
The syudy protocol is available on http://www.firm-act.org/documents/FIRM_ACT_S
Sponsors
Collaborative group for Adrenocortical Carcinoma Therapy (CO-ACT) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of adrenocortical carcinoma 2. Locally advanced or metastatic disease not amenable to radical surgical resection (Stage III-IV) 3. Radiologically monitorable disease 4. Eastern Cooperative Oncology Group (ECOG) performance status zero to two 5. Life expectancy more than three months 6. Age above 18 years 7. Adequate bone marrow reserve (neutrophils more than or equal to 1500/mm^3 and platelets more than or equal to 100,000/mm^3) 8. Effective contraception in pre-menopausal female and male patients 9. Patient?s written informed consent 10. Ability to comply with the protocol procedures (including availability for follow-up visits) 11. Previous palliative surgery, radiotherapy or radiofrequency ablation is acceptable as long as radiologically monitorable disease is verifiable afterwards.
Exclusion criteria
Exclusion criteria: 1. History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other cancers treated with no evidence of disease for at least five years 2. Previous cytotoxic chemotherapy (prior therapy with mitotane is allowed) for adrenocortical carcinoma 3. Renal insufficiency (serum creatinine more than or equal to 2 mg/dl or creatinine clearance less than or equal to 50 ml/min) 4. Hepatic insufficiency (serum bilirubin more than or equal to two times the institutional upper limit of normal range and/or serum transaminases more than or equal to three times the institutional upper limit of normal range; exception: in patients on mitotane transaminase levels up to five times the institutional upper limit of normal range are acceptable) 5. Pregnancy or breast feeding 6. Known hypersensitivity to any drug included in the treatment protocol 7. Presence of active infection 8. 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 9. Decompensated heart failure (ejection fraction less than 50%), myocardial infarction or revascularization procedure during the last six months, unstable angina pectoris, and uncontrolled cardiac arrhythmia 10. Current treatment with other experimental drugs and/or previous participation in clinical trials with other experimental agents for adrenocortical carcinoma 11. Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life as measured by EORTC QLQ-C30 2. Time to progression 3. Best overall response rate and duration of response 4. Number of disease-free patients 5. Impact of reaching mitotane blood levels between 14-20 mg/l in both arms on survival and best overall response rate 6. Best overall response rate of both regimens as second line treatment in case of failure of the initial other regime | — |
Countries
Australia, France, Germany, Italy, Netherlands, Sweden, United States of America
Outcome results
None listed