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Squamous Cell Carcinoma of the Head and NeckPhase 2RACATREXNCT01528163

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

A Phase 2 study testing Cabazitaxel and Methotrexate in people with Squamous Cell Carcinoma of the Head and Neck, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cabazitaxel and Methotrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
16 sitesin 2 countries
Study dates
Feb 2012to Nov 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation.
  • At least one measurable lesion by MRI or CT-scan according to RECIST 1.1.
  • 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.
  • ECOG performance status 0 -2, in stable medical condition
  • Patients must have an expected survival of at least 3 months
  • Paraffin-embedded tumor tissue available for immunohistochemistry but not mandatory
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  • Patients must be over 18 years old and must be able to give written informed consent.
  • 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).
  • 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.
  • Signed informed consent prior to beginning protocol specific procedure.
  • 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)

Who cannot join

  • Non-squamous head and neck cancer
  • Nasopharynx cancer
  • More than two lines of chemotherapy for palliative treatment
  • 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.
  • Previous treatment with cabazitaxel
  • 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
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  • Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
  • Previous malignancy from which the patient has been disease-free for < 5years, as other than SCCHN.
  • Previous treatments with taxanes and/or anti-EGFR therapy are not an exclusion criteria.
  • Active grade > 2 peripheral neuropathy
  • Active grade > 2 stomatitis
  • Known brain or leptomeningeal involvement
  • History of severe hypersensitivity reaction (> grade 3) to polysorbate 80 containing drugs
  • 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.
  • Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

Belgium15 sites

  • RHMS Baudour

    Baudour, Hainaut, 7331

  • Cliniques universitaires Saint-Luc, Centre du Cancer, Oncologie Médicale

    Brussels, Brussels Capital, 1200

  • Universitair Ziekenhuis Brussel (Campus Jette)

    Brussels, 1090

  • Grand Hôpital de Charleroi

    Charleroi, Hainaut, 6000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Hôpital de Jolimont

    Haine-Saint-Paul, Hainaut, 7100

  • CHU Tivoli Centre René Goffin

    La Louvière, Hainaut, 7100

  • CHR Citadelle

    Liège, 4000

  • CHU de Liège Sart Tilman

    Liège, 4000

  • CHU Ambroise PARE

    Mons, Hainaut, 7000

  • CHU de Charleroi site Vésale

    Montigny-le-Tilleul, Hainaut, 6110

  • Clinique et Maternité Sainte-Elisabeth

    Namur, 5000

  • Clinique Saint-Pierre

    Ottignies, Brabant Wallon, 1340

  • Centre Hospitalier Wallonie Picarde

    Tournai, Hainaut, 7500

  • CHU de Mont Godinne

    Yvoir, Namur, 5530

Other trials in Belgium

Luxembourg1 site

  • Centre Hospitalier de Luxembourg

    Luxembourg, L-1210

Other trials in Luxembourg

About this study

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.

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.

Read the 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.

Being tested
Cabazitaxel, Methotrexate
Keywords
Head and neck, Squamous cell carcinoma, Randomized, palliative treatment
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabazitaxelDrug

    Also called Jevtana

    from 20 mg/m2 to 25 mg/m2. Intravenous injection every three weeks.

  • MethotrexateDrug

    Also called Emthexate

    From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks.

Study groups in NCT01528163
Study groupRoleWhat they receive
CabazitaxelExperimentalCabazitaxel (XRP6258) is a new taxoid, which promotes tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel
Receives: Drug: Cabazitaxel
MethotrexateActive comparatorMethotrexate 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.
Receives: Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy

    Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks.

    Measured: 18 weeks

Secondary outcomes (1)

  1. Safety profile

    Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event

    Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01528163
Sponsor's protocol ID
UCL-ONCO 2011-01
Other IDs
2011-001938-42
Acronym
RACATREX
Status last verified
Jun 2017
First submitted
3 Feb 2012
Last updated
14 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Machiels JP, Van Maanen A, Vandenbulcke JM, Filleul B, Seront E, Henry S, D'Hondt L, Lonchay C, Holbrechts S, Boegner P, Brohee D, Dequanter D, Louviaux I, Sautois B, Whenham N, Berchem G, Vanderschueren B, Fontaine C, Schmitz S, Gillain A, Schoonjans J, Rottey S. Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-Based Therapy. Oncologist. 2016 Dec;21(12):1416-e17. doi: 10.1634/theoncologist.2016-0296. Epub 2016 Nov 30.

    PubMed 27903924

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabazitaxel and Methotrexate in people with Squamous Cell Carcinoma of the Head and Neck, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Belgium, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy (time frame: 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528163, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.

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