Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (RACATREX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor:
Information provided by (Responsible Party):
Jean-Pascal Machiels, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01528163
First received: February 3, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

In this clinical trial, the investigators want to know if cabazitaxel is more effective than methotrexate for patients with recurrent or metastatic squamous cell carcinoma of the head and neck in palliative treatment.


Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Drug: Cabazitaxel
Drug: Methotrexate
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 98
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabazitaxel
Cabazitaxel (XRP6258) is a new taxoid, which promotes tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel
Drug: Cabazitaxel
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.

Drug: Methotrexate
From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks.
Other Name: Emthexate

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation.
  2. At least one measurable lesion by MRI or CT-scan according to RECIST 1.1.
  3. Progressive disease within 1 year after first line platinum-based chemotherapy given either as a part of the multimodal curative treatment or in the palliative setting.
  4. ECOG performance status 0 -2, in stable medical condition
  5. Patients must have an expected survival of at least 3 months
  6. Paraffin-embedded tumor tissue available for immunohistochemistry but not mandatory
  7. Patients must be over 18 years old and must be able to give written informed consent.
  8. Women of child-bearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to enrollment).
  9. Patients must have adequate organ function (Hemoglobin ≥ 9 g/100 ml, Neutrophils ≥ 1,500/mm3, Platelets ≥ 100,000/mm3, total bilirubin <1 time the upper limit of normal (ULN) for age, serum alanine aminotransferase (ALT) < 1.5 1.5 x ULN for age, aspartate aminotransferase (AST) < 1.5 ´ ULN for age , serum creatinine <1.5 x ULN for age.
  10. Signed informed consent prior to beginning protocol specific procedure.
  11. Sexually active patients must use effective contraception during the period of therapy and up to 150 days after the last treatment dose. Acceptable contraception includes, but is not limited to: oral hormone therapy, partner vasectomy, or double barrier contraception (which is defined as a male condom plus spermicide in combination with either a female condom, or diaphragm, or cervical cap or intrauterine device)

Exclusion Criteria:

  1. Non-squamous head and neck cancer
  2. Nasopharynx cancer
  3. More than two lines of chemotherapy for palliative treatment
  4. Surgery or investigational drugs or chemotherapy within 4 weeks before study inclusion. Curative radiation therapy (60-70 Gy) within 8 weeks. For palliative radiation therapy (i.e 8 Gy on a painful lesion) no delay is needed.
  5. Previous treatment with cabazitaxel
  6. Significant active cardiac disease including: uncontrolled high blood pressure according to the CTCAE 4 grading, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias
  7. Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
  8. Previous malignancy from which the patient has been disease-free for < 5years, as other than SCCHN.
  9. Previous treatments with taxanes and/or anti-EGFR therapy are not an exclusion criteria.
  10. Active grade > 2 peripheral neuropathy
  11. Active grade > 2 stomatitis
  12. Known brain or leptomeningeal involvement
  13. History of severe hypersensitivity reaction (> grade 3) to polysorbate 80 containing drugs
  14. Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A/5. A one-week washout period is necessary for patients who are already on these treatments.
  15. Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528163

Contacts
Contact: Jean-Pascal Machiels, MD, PhD 003227645457 jean-pascal.machiels@uclouvain.be
Contact: Aline Gillain, Sc Degree 003227645470 aline.gillain@uclouvain.be

Locations
Belgium
Clinique Saint-Pierre Recruiting
Ottignies, Brabant Wallon, Belgium, 1340
Contact: Dora Barrientos       do.barrientos@clinique-saint-pierre.be   
Principal Investigator: Nicolas Whenham, MD         
Cliniques universitaires Saint-Luc, Centre du Cancer, Oncologie Médicale Recruiting
Brussels, Bruxelles Capitale, Belgium, 1200
Contact: Jean-Pascal Machiels, MD, PhD    003227645457    jean-pascal.machiels@uclouvain.be   
Contact: Aline Gillain, Sc Degree    003227645470    aline.gillain@uclouvain.be   
Principal Investigator: Jean-Pascal Machiels, MD, PhD         
RHMS Baudour Recruiting
Baudour, Hainaut, Belgium, 7331
Contact: Lorella Gaddi       lorella.gaddi@rhms.be   
Contact: Laurence Duvivier       laurence.duvivier@rhms.be   
Principal Investigator: Petra Boegner, MD         
Grand Hôpital de Charleroi Recruiting
Charleroi, Hainaut, Belgium, 6000
Contact: Janique Dewelle, PhD       janique.dewelle@ghdc.be   
Principal Investigator: Christophe Lonchay, MD         
Hôpital de Jolimont Recruiting
Haine-Saint-Paul, Hainaut, Belgium, 7100
Contact: Thècle Fourneaux       thecle.fourneaux@entitejolimontoise.be   
Principal Investigator: Dr Bertrand Filleul, MD         
CHU Tivoli Centre René Goffin Recruiting
La Louvière, Hainaut, Belgium, 7100
Contact: Claire Lepers    0032 64 27 77 33    claire.lepers@chu-tivoli.be   
Principal Investigator: Brigitte Vanderschueren, MD         
CHU Ambroise PARE Recruiting
Mons, Hainaut, Belgium, 7000
Contact: Anna Maria Barbuto    +32 065 39 22 83    anna-maria.barbuto@hap.be   
Principal Investigator: Stéphane Holbrechts, MD         
CHU de Charleroi site Vésale Recruiting
Montigny-Le-Tilleul, Hainaut, Belgium, 6110
Contact: Jolanta Szczebelska       jolanta.szczebelska@chu-charleroi.be   
Principal Investigator: Dany Brohee, MD         
Principal Investigator: Didier Dequanter, MD         
Centre Hospitalier Wallonie Picarde Recruiting
Tournai, Hainaut, Belgium, 7500
Contact: Arlette Dejehansart       arlette.dejehansart@chwapi.be   
Principal Investigator: Jean-Marie Vandenbulcke, MD         
CHU de Mont Godinne Recruiting
Yvoir, Namur, Belgium, 5530
Contact: Caroline Yague       caroline.yaguesanz@uclouvain.be   
Principal Investigator: Lionel D'Hondt, MD, PhD         
Universitair Ziekenhuis Brussel (Campus Jette) Recruiting
Brussel, Belgium, 1090
Contact: Christel Fontaine, MD       Christel.Fontaine@uzbrussel.be   
Contact: Nadia Cappoen, Study Nurse       nadia.cappoen@uzbrussel.be   
Principal Investigator: Christel Fontaine, MD         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Annie De Gussem       Annie.DeGussem@uzgent.be   
Contact: Anne Clue       Ann.Clue@uzgent.be   
Principal Investigator: Sylvie Rottey, MD         
CHU de Liège Sart Tilman Recruiting
Liège, Belgium, 4000
Contact: Hélène Schroeder, PhD       hschroeder@chu.ulg.ac.be   
Contact: Maude Piron, PhD       mpiron@chu.ulg.ac.be   
Principal Investigator: Brieuc Sautois, MD         
CHR Citadelle Recruiting
Liège, Belgium, 4000
Contact: Alexandra Van Eyck       alexandra.vaneyck@chrcitadelle.be   
Principal Investigator: Ingrid Louviaux, MD         
Clinique et Maternité Sainte-Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Cécile Ninane, SC Degree    +32 81 70 28 44    cecile.ninane@cmsenamur.be   
Principal Investigator: Stéphanie Henry, MD         
Luxembourg
Centre Hospitalier de Luxembourg Recruiting
Luxembourg, Luxembourg, L-1210
Contact: Anna Chioti       anna.chioti@crp-sante.lu   
Principal Investigator: Guy Berchem, MD         
Sponsors and Collaborators
Jean-Pascal Machiels
Investigators
Principal Investigator: Jean-Pascal Machiels, MD, PhD Centre du Cancer, Cliniques universitaires Saint-Luc
  More Information

No publications provided

Responsible Party: Jean-Pascal Machiels, Pr Jean-Pascal Machiels, MD, PhD - Centre du Cancer, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01528163     History of Changes
Other Study ID Numbers: UCL-ONCO 2011-01, 2011-001938-42
Study First Received: February 3, 2012
Last Updated: January 16, 2014
Health Authority: Luxembourg: Comite National d'Ethique de Recherche
Luxembourg: Ministère de la Santé

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Head and neck
Squamous cell carcinoma
Randomized
palliative treatment

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014