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.
The Efficacy and Safety of Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Principal Investigator: Nikki Neubauer, MD
Condition: Recurrent epithelial ovarian, recurrent fallopian tube, and recurrent primary peritoneal cancers
Institution: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
In this single-arm phase II trial, all patients will receive 1.5 mg orally of tivozanib given daily for 3 weeks, with 1 week off to complete a 4-week cycle. At the start of each cycle, patients will visit a clinician who will obtain a pertinent history, perform a physical examination, measure serum CA-125 values, and determine whether the patient is appropriate for therapy. Treatment will continue until documented disease progression or the patient is unable to tolerate further therapy because of excessive toxicity. Statistical analyses will focus on estimating overall response rates in patients with platinum-resistant ovarian cancer as stated in the primary objective. For the secondary objective, the Kaplan-Meier method will be used to estimate the median and overall distribution of progression-free survival. Toxicity will also be evaluated as a secondary objective and grades will be summarized by counts and frequencies.
Primary Objective:
Determine the clinical activity of tivozanib in patients with platinum-resistant, recurrent ovarian, fallopian tube, or primary peritoneal cancer, referred to collectively as ovarian cancer
Secondary Objective:
Determine the potential survival advantage and characterize the safety of single-agent tivozanib in patients with platinum-resistant ovarian cancer
Contact: Nikki Neubauer, MD • 312-472-4684 Rachel Bers, BS • 312-472-5726 • r-bers@northwestern.edu
ClinicalTrials.gov Identifier: NCT01853644
Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity
Principal Investigator: Mihaela Cristea, MD
Condition: Ovarian cancer, peritoneal cavity cancer
Institution: City of Hope Comprehensive Cancer Institute and Swedish Medical Center
Patients receive intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Plasma and peritoneal fluid samples are collected on cycle 1, day 1 and cycle 1, day 8 for pharmacokinetic analysis using liquid chromatography and mass spectrometry. After completion of study treatment, patients are followed for 4 weeks.
Primary Objective:
Determine the maximally tolerated dose of nab-paclitaxel (Abraxane) as a single agent administered intraperitoneally via an intraperitoneal catheter
Secondary Objectives:
Evaluate the pharmacokinetics of nab-paclitaxel (Abraxane) in the plasma and peritoneum when administered directly into the peritoneal cavity
Determine the potential pharmacokinetic advantage (favorable ratio of nab-paclitaxel [Abraxane] concentration in the peritoneal cavity vs plasma) for nab-paclitaxel (Abraxane) administered intraperitoneally
Determine the progression of peripheral neuropathy in patients treated with intraperitoneal chemotherapy on this study through pretreatment and sequential evaluation of the Neuropathic Pain Syndrome Inventory and Serial Nerve Conduction Studies
Contact: Clinical Trials Office - City of Hope Medical Center • 800-826-4673 • becomingapatient@coh.org
ClinicalTrials.gov Identifier: NCT00825201
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.
