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.
Neoadjuvant Weekly nab-Paclitaxel (Abraxane) Plus Carboplatin Followed by Doxorubicin Plus Cyclophosphamide With Bevacizumab Added Concurrently to Chemotherapy for Palpable and Operable Triple-Negative Invasive Breast Cancer
Principal Investigator: Jasgit C. Sachdev, MD
Condition: Triple-negative breast cancer
Institutions: University of Tennessee Cancer Institute, The West Clinic, and The Center for Cancer and Blood Disorders
The purpose of this study is to determine how well this combination of chemotherapy drugs works with bevacizumab in eliminating primary tumor in the breast before surgery (pathologic complete response [pCR] in the breast). Bevacizumab is a drug that works through blocking new blood vessel formation by tumor cells. Giving chemotherapy and bevacizumab before surgery may allow for removal of a lesser amount of breast tissue. To predict which patients are more likely to achieve a pCR with this drug combination, specialized tests will be performed on fresh tumor tissue collected before the start of treatment.
Major Eligibility Criteria:
Patients with histologically proven estrogen receptor–, progesterone receptor–, and HER2-negative (triple-negative) breast cancer that is ≥ 2 cm, clinically palpable, and considered operable are eligible. Patients with T4 and inflammatory cancers are ineligible.
Primary Objective:
pCR in the breast
Secondary Objectives:
Determine the rate of near pCR defined as ≤ 0.5 cm of residual invasive tumor in the breast.
Determine the rate of pCR in the breast and axillary nodes and nonaxillary sentinel nodes (pCR breast and nodes).
Determine clinical response rates (cRR; complete plus partial response rates) after treatment with 4 cycles of nab-paclitaxel plus carboplatin with concurrent bevacizumab.
Determine cRR after treatment with all 8 cycles of neoadjuvant treatment.
Determine the rate of breast-conserving surgery after completion of neoadjuvant therapy.
Determine safety and tolerability of the above regimen, including cardiac safety.
Determine disease-free survival.
Identify genes that may predict pCR to the study regimen.
Contact: Steve K. West, BS, CCRP • 901-722-0581 • steve.west@bmhcc.org
ClinicalTrials.gov Identifier: NCT00777673
A Phase II Study of Axitinib in Advanced Carcinoid Tumors
Principal Investigators: Jonathan Strosberg, MD, and Emily Bergsland, MD
Condition: Carcinoid tumor
Institutions: Moffitt Cancer Center and the University of California, San Francisco This is a bi-institutional, prospective, open-label phase II study. The target population consists of adult patients with histologically confirmed unresectable or metastatic carcinoid tumors. Carcinoid tumors are defined as well- to moderately differentiated neuroendocrine tumors of the digestive tract and lungs. Patients with metastatic carcinoid tumors of unknown primary and rare primaries (renal, ovarian, thymic, hepatic) will also be eligible.
Axitinib is a selective inhibitor of receptor tyrosine kinases with picomolar potency against vascular endothelial growth factor (VEGF) receptors 1, 2, and 3, and nanomolar potency against platelet-derived growth factor receptor β. It is a particularly promising agent for the treatment of metastatic carcinoid tumors because of its specificity towards the VEGF receptor and favorable toxicity profile. The hypothesis is that potent and selective inhibition of the VEGF pathway will result in prolonged disease stability among patients with progressive advanced carcinoid tumors. Thus, in contrast to previous phase II studies with other VEGF receptor tyrosine kinase inhibitors, this study will focus on progression-free survival (PFS) as the primary trial end point (rather than response rate). Based on pharmacokinetic modeling and efficacy data in the phase I study described earlier, patients will be treated at the recommended phase II dose level of 5 mg twice daily. Patients will be followed for the primary end point of PFS.
Primary Objective:
Determine the PFS associated with axitinib in patients with advanced (unresectable or metastatic) carcinoid tumors.
Determine the 12-month rate of PFS in this population.
Secondary Objectives:
Overall survival
Overall response rate
Time to treatment failure
Safety and tolerability
Biochemical response rate by measuring chromogranin A and urine 5-hydroxyindoleacetic acid
Exploratory Objectives:
Correlate response to therapy with baseline mitotic rate and Ki67 labeling index.
Contact: Jonathan Strosberg, MD • 813-745-7257 • jonathan.strosberg@moffitt.org
ClinicalTrials.gov Identifier: NCT01435122
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 NCCN.org/clinical_trials/clinicians.asp.
