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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.

Phase 2
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

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.

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.

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

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

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

15. Organic brain syndrome or significant psychiatric abnormality that would preclude
participation in the full protocol and follow up.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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

Outcome Time Frame:

18 weeks

Safety Issue:


Principal Investigator

Jean-Pascal Machiels, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre du Cancer, Cliniques universitaires Saint-Luc


Luxembourg: Comite National d'Ethique de Recherche

Study ID:

UCL-ONCO 2011-01



Start Date:

February 2012

Completion Date:

December 2015

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Head and neck
  • Squamous cell carcinoma
  • Randomized
  • palliative treatment
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms