Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (RACATREX)
Squamous Cell Carcinoma of the Head and Neck
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Therapy.|
- Efficacy [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks.
- Safety profile [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event
|Study Start Date:||February 2012|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Cabazitaxel (XRP6258) is a new taxoid, which promotes tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel
from 20 mg/m2 to 25 mg/m2. Intravenous injection every three weeks.
Other Name: Jevtana
Active Comparator: Methotrexate
Methotrexate is the historical control and has been widely used in SCCHN for palliation.
This medication is an antimetabolite and antifolate drug. It acts by inhibiting the metabolism of folic acid.
From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks.
Other Name: Emthexate
The principal aim is to evaluate the efficacy of cabazitaxel in patients with palliative head and neck previously treated with platinum-based therapy.
The study design is a non comparative randomized phase II trial: ARM 1: cabazitaxel (20 mg/m2, every 3 weeks) versus ARM 2 methotrexate (40 mg/m2, weekly). Cabazitaxel dose will be increased to 25mg/m2 for the second and subsequent cycles, in the absence of non-hematological AE > grade 2 and hematological AE > grade 3 during the first cycle. (maximum 10 cycles). The aim of the randomization is to offer a valid internal control group by avoiding possible selection bias. However, results obtained in the two treatment group will not be formally compared as this is not the objective of a phase II study.
Tumor check-up will be performed every 9 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. A maximum of 10 cycles of cabazitaxel will be given.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528163
|Ottignies, Brabant Wallon, Belgium, 1340|
|Cliniques universitaires Saint-Luc, Centre du Cancer, Oncologie Médicale|
|Brussels, Bruxelles Capitale, Belgium, 1200|
|Baudour, Hainaut, Belgium, 7331|
|Grand Hôpital de Charleroi|
|Charleroi, Hainaut, Belgium, 6000|
|Hôpital de Jolimont|
|Haine-Saint-Paul, Hainaut, Belgium, 7100|
|CHU Tivoli Centre René Goffin|
|La Louvière, Hainaut, Belgium, 7100|
|CHU Ambroise PARE|
|Mons, Hainaut, Belgium, 7000|
|CHU de Charleroi site Vésale|
|Montigny-Le-Tilleul, Hainaut, Belgium, 6110|
|Centre Hospitalier Wallonie Picarde|
|Tournai, Hainaut, Belgium, 7500|
|CHU de Mont Godinne|
|Yvoir, Namur, Belgium, 5530|
|Universitair Ziekenhuis Brussel (Campus Jette)|
|Brussel, Belgium, 1090|
|Universitair Ziekenhuis Gent|
|Gent, Belgium, 9000|
|Liège, Belgium, 4000|
|CHU de Liège Sart Tilman|
|Liège, Belgium, 4000|
|Clinique et Maternité Sainte-Elisabeth|
|Namur, Belgium, 5000|
|Centre Hospitalier de Luxembourg|
|Luxembourg, Luxembourg, L-1210|
|Principal Investigator:||Jean-Pascal Machiels, MD, PhD||Centre du Cancer, Cliniques universitaires Saint-Luc|