Oncology Research Program

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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.

Predictive Markers of Response in a Phase II Trial of Axitinib in Advanced Melanoma

Principal Investigator: Nikhil I. Khushalani, MD

Conditions: Recurrent melanoma; stage IIIA, IIIB, IIIC, and IV melanoma

Institution: Roswell Park Cancer Institute

This is a phase II study of single-agent axitinib in the treatment of patients with advanced melanoma to determine the efficacy and safety in this setting.

Primary Objective:

  • Determine the overall response rate to axitinib in advanced melanoma. This will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

Secondary Objectives:

  • Evaluate toxicity of axitinib as a single agent

  • Determine progression-free survival and overall survival

  • Explore the utility of FLT-PET as a predictive marker for response versus standard radiographic imaging

Correlative Science Objectives:

  • Examine the prognostic and predictive significance of circulating melanoma tumor cells

  • Examine whether functionally relevant polymorphisms in axitinib-related genes (VEGFR 1, 2, and 3) correlate with efficacy and toxicity of axitinib in advanced melanoma

Contact: Roswell Park Cancer Institute • 877-275-7724 • AskRPCI@roswellpark.org

ClinicalTrials.gov Identifier: NCT01533948

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

Conditions: Ovarian cancer, peritoneal cavity cancer

Institutions: City of Hope Comprehensive Cancer Center 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 by 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 http://www.nccn.org/clinical_trials/clinicians.asp.

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