Carcinoma, Adrenal Cortical Clinical Trial
Official title:
First International Randomized Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment
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.
The Firm-ACT trial is the first ever conducted randomized controlled phase III trial in
adrenocortical carcinoma (ACC), a rare malignancy with poor prognosis. It will provide
results leading to the establishment of an urgently needed gold standard chemotherapy
regimen for patients with locally advanced or metastatic ACC. To this end the trial compares
the two most promising drug combinations investigated in phase II trials, considered by the
"International Consensus Conference on Adrenal Cancer" (Ann Arbor/USA, 2003) as valuable
first line treatments for advanced ACC. The first regimen consists of etoposide,
doxorubicin, cisplatin plus mitotane (EDP-M), the second regiment employs streptozotocin
plus mitotane (Sz-M). Over a period of five years this international trial will include 300
patients with advanced ACC from different European countries. Blood mitotane concentrations
will be monitored, aiming at drug levels between 14 - 20 mg/L. Patients not responding to
the first line treatment will be switched to the alternative regimen. The primary objective
of this trial is to investigate whether EDP-M given as first line treatment will prolong
survival as compared to Sz-M. Secondary endpoints are quality of life, time to progression,
best overall response rate and duration of response. In addition, the trial evaluates the
role of reaching therapeutic mitotane serum concentrations for survival and tumour response
and assesses the value of the two alternative treatment regimens as second line therapy in
advanced ACC. Moreover, the FIRM-ACT trial will generate a lasting structural basis for
successful future trials in ACC.
In a substudy of 40 patients a detailed analysis of the pharmacokinetics of oral mitotane
will be analysed. Two different mitotane treatment regimens ("low dose" vs. "high dose")
will be compared.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06041516 -
Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas
|
Phase 1 |