Highlights of the NCCN Oncology Research Program

The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program’s establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.

NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.

NCCN studies funded through the grant mechanism are highlighted below.

Phase II Trial Evaluating Axitinib (AG-013736) in Patients With Unresectable, Recurrent, or Metastatic Head and Neck Cancer

Principal Investigator: Francis P. Worden, MD

Condition: Head and neck squamous cell carcinoma

Institution: University of Michigan Comprehensive Cancer Center

Given that growth factors and cytokines have been implicated in the growth of cancer cells in head and neck tumors, administration of axitinib should result in tumor control in recurrent or metastatic head and neck squamous cell carcinoma, thus improving disease-free and overall survivals in these patients, with a tolerable toxicity profile. Hence, a phase II is being conducted to evaluate outcomes in these patients. Patients are now being enrolled and some have attained meaningful responses to treatment thus far.

Axitinib l produces its antitumor effect through influencing the signaling pathways of VEGF/VEGFR, EGF/EGFR, PDGF/PDGFR-β, IL-6, IL-8, HGF/c-met, FGF/FGFR, Jak2, and STAT3, and their effects on microvessel density in the tumors. Therefore, it is postulated that assessing the levels and activity of these molecules before and during axitinib treatment will allow the identification of patients whose disease will respond to this treatment in a clinically meaningful way, thus providing a predictive tool for this therapy.

Primary Objective:

• Determine the 6-month progression-free survival (PFS) rate in patients with unresectable recurrent and metastatic head and neck cancer treated with axitinib

Secondary Objectives:

• Determine the objective response rate (complete and partial response) and disease control rate (complete response + partial response + stable disease) in patients with unresectable recurrent and metastatic head and neck cancer treated with axitinib

• Determine the overall survival of these patients treated with axitinib

• Assess the toxicities associated with the treatment of axitinib in this patient population

• Evaluate 2- and 4-month PFS rates in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with axitinib

Correlative Studies:

• Investigate the dynamics between VEGF, EGF, PDGF, HGF, and FGF and their receptors, and IL-6, IL-8, Jak2, and STAT3, upon treatment with axitinib

• Correlate these data, and patients’ human papillomavirus status and tumor microvessel density, with clinical outcomes, such as degree of response, PFS, and overall survival

• Develop a prognostic and/or predictive pattern of these changes that would allow the prospective selection of patients who are likely to benefit from axitinib therapy

Contact: Cancer Answer Line: 800-865-1125

ClinicalTrials.gov Identifier: NCT01469546