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

NCT01528163 | Completed Phase 2 DMC

• 2 other identifiers: UCL-ONCO 2011-012011-001938-42
• Study Type: interventional
• Target: 101
• Locations: 2 countries
• Sites: 16

Brief 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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Head and neck; Squamous cell carcinoma; Randomized; palliative treatment

Outcome Measures

Primary Outcomes (1)

• Efficacy

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

  18 weeks

Secondary Outcomes (1)

• Safety profile

  18 weeks

Study Arms (2)

Cabazitaxel

EXPERIMENTAL

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

Methotrexate

ACTIVE COMPARATOR

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

Interventions

Cabazitaxel DRUG

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

Also known as: Jevtana

Cabazitaxel

Methotrexate DRUG

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

Also known as: Emthexate

Methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• Non-squamous head and neck cancer
• Nasopharynx cancer
• More than two lines of chemotherapy for palliative treatment
• 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
• 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.
• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (16)

Clinique Saint-Pierre

Ottignies, Brabant Wallon, 1340, Belgium

Location

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

Brussels, Brussels Capital, 1200, Belgium

Location

RHMS Baudour

Baudour, Hainaut, 7331, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6000, Belgium

Location

Hôpital de Jolimont

Haine-Saint-Paul, Hainaut, 7100, Belgium

Location

CHU Tivoli Centre René Goffin

La Louvière, Hainaut, 7100, Belgium

Location

CHU Ambroise PARE

Mons, Hainaut, 7000, Belgium

Location

CHU de Charleroi site Vésale

Montigny-le-Tilleul, Hainaut, 6110, Belgium

Location

Centre Hospitalier Wallonie Picarde

Tournai, Hainaut, 7500, Belgium

Location

CHU de Mont Godinne

Yvoir, Namur, 5530, Belgium

Location

Universitair Ziekenhuis Brussel (Campus Jette)

Brussels, 1090, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

CHR Citadelle

Liège, 4000, Belgium

Location

CHU de Liège Sart Tilman

Liège, 4000, Belgium

Location

Clinique et Maternité Sainte-Elisabeth

Namur, 5000, Belgium

Location

Centre Hospitalier de Luxembourg

Luxembourg, L-1210, Luxembourg

Location

Related Publications (1)

• 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.

  PMID: 27903924 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Interventions

cabazitaxel; Methotrexate

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean-Pascal Machiels, MD, PhD

  Centre du Cancer, Cliniques universitaires Saint-Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

LU (1); BE (15)