Head and Neck Cancer Clinical Trial
Official title:
LCCC 1330 - A Phase II Study of Weekly Carboplatin, Paclitaxel and Cetuximab for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
This is a non-randomized, open-label phase II trial of 38 patients with recurrent or metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuximab. Following assessment of response, the treating physician at their discretion may continue to treat with weekly cetuximab as maintenance until disease progression. The study is designed to evaluate whether this regimen improves median overall survival (OS) as compared to an historical control population treated with a platinum plus 5-fluorouracil (5-FU). There is currently no agreed upon first line therapy for recurrent or metastatic SCCHN; regimen options are highly toxic, inconvenient and resource intensive. Our study regimen has been used extensively for induction therapy and off-protocol in palliative care, but treatment outcomes have yet to be defined by a clinical trial.
Because of their high response rates and low toxicity, the taxane, carboplatin, cetuximab
regimens have frequently been adapted for use in the palliative setting. At UNC, we have
observed high rates of response, leading to symptomatic benefit and low toxicity. Further,
the regimen de-medicalizes the patient's life in several important ways. First, unlike with
the EXTREME regimen, no PORT or 4 day infusion is required. Second, the regimen gives only
six weeks of cytotoxic therapy. Finally, in our experience there is a low rate of severe
toxicity and this, coupled with the high rate of response, may improve quality of life. We
are not aware of any presented or published results on the use of this combination in
palliative therapy; with the adoption of this regimen in clinical practice, documentation of
its benefit via conduct of a clinical trial is needed.
We propose a study designed to detect an improvement in median OS versus a historical
control. The control arm from the EXTREME trial achieved a median OS of 7.4 months. We
hypothesize that a less toxic and more effective 3-drug regimen will result in improved
median OS compared with the control arm from EXTREME (median 7.4 months). The toxicity
associated with EXTREME is primarily attributable to the cisplatin and 5FU cytotoxic backbone
as its toxicity has been consistent in multiple studies of both palliative therapy and
induction therapy. If a 4-month improvement in OS is achieved with acceptable toxicity, we
will consider this regimen worth of further study.
Secondary objectives will include characterizing changes in quality of life (QoL), symptoms
and toxicities. Patients will be encouraged to co-enroll into the UNCseq protocol for further
exploration of associations between genetic changes and clinical outcomes.
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