Clinical trial NCT01528163: Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Head and neck
Squamous cell carcinoma
Randomized
palliative treatment
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Efficacy
timeFrame: 18 weeks
Secondary outcomes:
measure: Safety profile
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre
state: Brabant Wallon
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc, Centre du Cancer, Oncologie Médicale
state: Bruxelles Capitale
city: Baudour
country: Belgium
facility: RHMS Baudour
state: Hainaut
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
city: Haine-Saint-Paul
country: Belgium
facility: Hôpital de Jolimont
state: Hainaut
city: La Louvière
country: Belgium
facility: CHU Tivoli Centre René Goffin
state: Hainaut
city: Mons
country: Belgium
facility: CHU Ambroise PARE
state: Hainaut
city: Montigny-Le-Tilleul
country: Belgium
facility: CHU de Charleroi site Vésale
state: Hainaut
city: Tournai
country: Belgium
facility: Centre Hospitalier Wallonie Picarde
state: Hainaut
city: Yvoir
country: Belgium
facility: CHU de Mont Godinne
state: Namur
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel (Campus Jette)
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liège
country: Belgium
facility: CHR Citadelle
city: Liège
country: Belgium
facility: CHU de Liège Sart Tilman
city: Namur
country: Belgium
facility: Clinique et Maternité Sainte-Elisabeth
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
Study officials:
affiliation: Centre du Cancer, Cliniques universitaires Saint-Luc
name: Jean-Pascal Machiels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.