Phase I Study of Cabazitaxel - Platinum Fluorouracil Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
The primary study objectives are the following:
- To assess the safety, the maximum tolerated dose (MTD) and the dose limiting toxicity
of cabazitaxel when combined with cisplatin and Follow-Up (FU) induction chemotherapy
in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
- To establish the phase II recommended dose of cabazitaxel when combined with cisplatin
and Follow-Up induction in patients with locally advanced squamous cell carcinoma of
the head and neck.
The secondary study objectives, in regards to the combined Cabazitaxel-Platinum Fluorouracil
regimen in patients with newly diagnosed squamous cell carcinoma of the head and neck, are
- To assess the toxicity profile
- To assess best Overall Response Rate (complete and partial responses) after completion
of 3 cycles of treatment
- To assess Progression Free Survival (PFS) and Overall Survival (OS) after 3 years
Analysis of the secondary variables will be primarily descriptive in nature due to the
small sample size. All results will be considered hypothesis generating to be
confirmed in a future study.
Patient, for whom an informed consent has been obtained and who have met the
inclusion/exclusion criteria after having the screening evaluation performed within a
one-week window, will be assigned to a dose level according to the dose escalation rule
described in the protocol. Treatment consists of an Induction chemotherapy period, which is
the period when the patient will undergo 3 cycles of Cabazitaxel-Platinum Fluorouracil (PF).
The Induction chemotherapy will be followed by Consolidation Therapy, which is 6-7 weeks of
Chemoradiation treatment or Surgery + Recovery time, depending on their primary site and
overall medical condition. Both treatment periods will consist of approximately 16 weeks (9
weeks of Induction and 7 weeks of Consolidation, if Chemoradiation Radiation Therapy (CRT)),
or shorter than 16 weeks, if surgery. After three cycles, the patients will be assessed for
clinical, radiographic, and pathologic response to Cabazitaxel-Platinum Fluorouracil before
beginning Chemoradiation Radiation Therapy or surgery. Patients, who do not complete three
cycles of Cabazitaxel-Platinum Fluorouracil for reasons of toxicity, progressive disease,
choice, or other medical necessity, will be treated with standard Chemoradiation Radiation
Therapy or surgery depending on their primary site and overall medical condition. Once the
Consolidation treatment is completed, the follow-up of patients will be for 3 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
MTD is defined as the dose level immediately below the DLT. The study will be conducted until MTD and recommended Phase II dose are established.
at 3 weeks
Krzysztof Misiukiewicz, M.D.
Mount Sinai School of Medicine
United States: Institutional Review Board
|Mount Sinai School of Medicine||New York, New York 10029|