Status:
COMPLETED
Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pall...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01528163
Start Date
February 1 2012
End Date
November 1 2014
Last Update
June 14 2017
Active Locations (16)
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1
Clinique Saint-Pierre
Ottignies, Brabant Wallon, Belgium, 1340
2
Cliniques universitaires Saint-Luc, Centre du Cancer, Oncologie Médicale
Brussels, Brussels Capital, Belgium, 1200
3
RHMS Baudour
Baudour, Hainaut, Belgium, 7331
4
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium, 6000