drugset / Trial / NCT00094497
Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
Phase 3
Completed
304 enrolled
Collaborative Group for Adrenocortical Carcinoma Treatment
German Federal Ministry of Education and Research · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2004-06
- Primary completion
- 2010-12
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 40 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 40 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | — |
| Comparator | Mitotane | Small molecule | — | Oral |
| Comparator | streptozocin | Small molecule | 2 g | — |