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-sponsored 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
Conditions: 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 metastatic or recurrent squamous cell carcinomas of the head and neck (R/M SCCHN) patients, thereby improving disease-free and overall survival (OS) with a tolerable toxicity profile. This phase II study is evaluating outcomes in patients with R/M SCCHN. While accrual is ongoing, some currently enrolled patients have attained meaningful responses to treatment thus far.
Axitinib produces its antitumor effect through influencing the signaling pathways of VEGF/VEGFR, EGF/EGFR, PDGF/PDGFR-beta, IL-6, IL-8, HGF/c-met, FGF/FGFR, Jak2, STAT3, and effect on microvessel density in the tumors. Therefore, the investigators postulate that assessing the levels and activity of these molecules before and during Axitinib treatment will allow physicians to identify patients who will respond in a clinically meaningful way, thus providing a predictive tool for such therapy.
Primary Objective:
Determine the 6-month progression-free survival (PFS) rate in patients with unresectable R/M SCCHN treated with Axitinib.
Secondary Objectives:
Determine the objective response rate (complete and partial response), and the 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 OS of these patients treated with Axitinib.
Assess toxicities associated with Axitinib treatment in this patient population.
Evaluate 2- and 4-month PFS rates in patients with R/M SCCHN treated with Axitinib.
Correlative Science Objectives:
Investigate the dynamics between VEGF, EGF, PDGF, HGF, FGF and their receptors, as well as IL-6, IL-8, Jak2, and STAT3 upon treatment with axitinib.
Correlate these data, as well as patients’ HPV status and tumor microvessel density, with clinical outcomes, such as degree of response, PFS, and OS.
Develop a prognostic and/or predictive pattern of changes that would allow prospective selection of patients who are likely to benefit from axitinib therapy.
Contact: Cancer Answer Line: 800-865-1125
ClinicalTrials.gov Identifier: NCT01469546
A Phase I Study of Bendamustine and Bevacizumab for Patients With Advanced Cancers
Principal Investigator: Apostolia M. Tsimberidou, MD, PhD
Conditions: Advanced cancers
Institutions: The University of Texas MD Anderson Cancer Center
Designed as a standard 3 + 3 study with expansion at maximum tolerated dose (MTD), the goal of this clinical research study is to assess tolerability and antitumor activity of bendamustine combined with bevacizumab in patients with advanced cancer. Drug combination safety will also be studied.
Objectives:
Determine the MTD, dose-limiting toxicities (DLTs), and tolerability of bendamustine and bevacizumab in patients with advanced cancers.
Assess the antitumor efficacy of this combination regimen.
Currently, 23 patients have been enrolled in the study, with 22 treated. In addition, 4 dose levels have been completed without any DLTs. The expansion dose (level 4) is still accruing with 4 active patients; the MTD has not yet been reached at this dose level, the maximum dose tested.
Antitumor activity has been noted as follows:
NSCLC: 1 of 4 patients had stable disease (SD) for 4 cycles; treatment is ongoing
Squamous cell carcinoma of the thymus: 1 of 1 patient treated had SD after 2 cycles, but was taken off-study due to complications from pre-existing lupus
Metastatic adenocarcinoma of the lung: 1 of 1 patient had SD after 2 cycles
Esophageal cancer: 1 of 1 patient had SD after 2 cycles
Salivary gland adenoid cystic carcinoma: 1 of 1 patient has SD after 6 cycles (decrease in tumor size by 28% by RECIST criteria); patient is currently on cycle 7
Breast cancer, ER-positive, PR-negative, HER2/neu-negative: SD after 2 cycles (-6%); cycle 3 has been initiated
It is too early for response assessments on other active patients.
Contact: Apostolia M. Tsimberidou, MD, PhD • 713-792-4259
Study Coordinator: Adoneca Fortier • pager: 713-606-5564
ClinicalTrials.gov Identifier: NCT01152203
The goal of the Highlights of the NCCN Oncology Research Program (ORP) is to provide readers with more information on the ORP, including studies currently accruing patients.
For more information on specific trials, including patient selection criteria, please use the contact information listed with each study.
For more information on the NCCN ORP, including a complete detailing of the clinical studies currently underway at NCCN Member Institutions, please access the NCCN ORP pages at http://www.nccn.org/clinical_trials/clinicians.asp.
