Stage IVA Oropharyngeal Squamous Cell Carcinoma Clinical Trial
Official title:
A Molecularly Driven Pilot Study of Preoperative Ganetespib in Resectable Squamous Cell Carcinoma of the Head and Neck (SCCHN)
This pilot clinical trial studies how well ganetespib works before surgery in treating patients with stage I-IVA squamous cell carcinoma of the head and neck that can be removed by surgery. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying samples of blood and tissue in the laboratory from patients receiving ganetespib may help doctors learn more about the effects of ganetespib on cells. It may also help doctors understand how well patients respond to treatment.
Ganetespib is a small molecule inhibitor of HSP90 that is currently being studied in several
ongoing clinical trials. Investigators have demonstrated that ganetespib sensitizes
colorectal cell lines to the effects of chemo radiotherapy in vitro. Ganetespib may have an
anti-tumor effect in head and neck cancer. The investigators propose this pilot study as a
first step to examine the activity of ganetespib in patients with locally advanced squamous
cell carcinoma of the head and neck (SCCHN) who have a planned surgical resection.
Ganetespib has not been investigated in SCCHN. This protocol is a window of opportunity
trial that will be looking at whether there is a rationale for pursuing this agent in future
development of clinical trials that would then focus on therapeutic interventions with or
without radiotherapy. There are therefore no clinical trials currently opened using
ganetespib in SCCHN and listed on ClinicalTrials.gov. It is not clear if patients who
receive this drug prior to surgery will benefit from this intervention.
In this study, ganetespib will be administered twice weekly (doses approximately 72 hours
apart) for 2 weeks, followed by surgery the day after the last dose of the study drug. There
will be 3 dose levels, 80, 100 and 150mg/m² as highest dose. These doses were chosen based
on the following considerations. In a Phase 1 study (protocol 9090-01) investigating a
twice-weekly ganetespib treatment schedule, doses up to 173 mg/m² were well tolerated, with
manageable diarrhea and fatigue being the most common adverse events. Extensive correlative
studies and pharmacokinetic (PK)/pharmacodynamic (PD) modeling of preclinical data suggest
that in humans the effective dose range for ganetespib is 70-150 mg/m². Therefore, 80 mg/m²
is within the range of ganetespib effectiveness and 150 mg/m² twice weekly is a
well-tolerated dose.
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Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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