Androgen-independent Prostate Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Mitoxantrone vs. Mitoxantrone With Cetuximab in Metastatic Androgen Independent Prostate Cancer (AIPC) Previously Treated With Docetaxel-based Chemotherapy
To determine the time to progression produced by the combination of Novantrone (mitoxantrone) and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously treated with docetaxel-based chemotherapy. TTP is defined as time from the start of treatment date to the date the patient is first recorded as having disease progression, even in patients who discontinue study treatment early due to toxicity.
This is a nonblinded, randomized phase II study to determine the activity of Novantrone
(mitoxantrone) with or without Erbitux (cetuximab) in patients with androgen independent
prostate cancer (AIPC) who have been treated previously with docetaxel chemotherapy. The
Novantrone (mitoxantrone)-only treatment arm will serve as a concurrent control arm to aid
in the determination of the benefit of the Novantrone (mitoxantrone)-Erbitux (cetuximab)
combination in this setting.
Patients will be randomly assigned 2:1 to 1 of 2 treatment arms; 93 patients in Arm 1 and 47
patients in Arm 2. A balanced randomization procedure will be performed utilizing a code
list that will be developed prior to the study opening. Because the patients will be
stratified by performance status (ECOG 0 and 1 vs. ECOG 2), the list will be developed to
ensure a balance between the 2 treatment arms.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02055846 -
Analysis of the Mechanisms of Actions of Heat Shock Protein (Hsp27) Responsible of the Androgen-independent Evolution in Prostate Cancer
|
N/A | |
| Recruiting |
NCT02049190 -
Phase 1-2 Study of Onapristone in Patients With Advanced Castration-resistant Prostate Cancer
|
Phase 1/Phase 2 |