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.

A Phase I/II Study of the Combination of Temozolomide and Pazopanib in Advanced Pancreatic Neuroendocrine Tumors

Principal Investigator: Halla Nimeiri, MD

Condition: Pancreatic alpha cell carcinoma, pancreatic beta islet cell carcinoma, pancreatic delta cell carcinoma, pancreatic G-cell carcinoma, recurrent islet cell carcinoma

Institution: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib hydrochloride when given together and to see how well they work in treating patients with advanced pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth. Giving temozolomide together with pazopanib hydrochloride may be an effective treatment for patients with PNET.

Phase I Primary Objective:

  • Determine the maximum tolerated dose of temozolomide and pazopanib combination in patients with advanced PNET

Phase I Secondary Objectives:

  • Determine safety and toxicity profile

  • Describe the pharmacokinetics of temozolomide alone and in combination with pazopanib

  • Observe the overall response rate (ORR)

Phase II Primary Objective:

  • Determine the ORR

Phase II Secondary Objectives:

  • Determine progression free survival (PFS) and overall survival, disease control rate, and duration of response

  • Determine the safety and toxicity profile of the combination in a larger cohort of patients

Exploratory/Correlative Objectives:

  • Examine the relationship between tumor blood flow, as measured by perfusion functional computed tomography, and overall response

  • Correlate the expression of tissue methyl–guanine methyl transferase as measured by immunohistochemistry with ORR and PFS

Contact: Northwestern University Study Coordinator • 312-695-1301 • cancertrials@northwestern.edu

ClinicalTrials.gov Identifier: NCT01465659

Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-Based Therapy

Principal Investigator: Jeffrey S. Rose, MD

Condition: Adenocarcinoma of the esophagus, adenocarcinoma of the gastroesophageal junction, recurrent esophageal cancer, squamous cell carcinoma of the esophagus, stage IV esophageal cancer

Institution: The Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute

Pralatrexate is a dihydrofolate reductase inhibitor leading to interference with DNA synthesis and subsequent death of tumor cells. Docetaxel, an established therapy in esophageal carcinoma, binds to microtubules and ultimately inhibits cell division by mitosis. Drugs used in chemotherapy, such as docetaxel and pralatrexate, work in different ways to stop the growth of tumor cells, by either killing the cells or stopping them from dividing. It is proposed that administering pralatrexate together with docetaxel may kill more tumor cells and thus improve survival in patients with esophageal cancers.

The purpose of this phase II trial is studying how well giving pralatrexate together with docetaxel works in treating patients with stage IV esophageal or gastroesophageal cancer for whom platinum-based therapy has failed.

Primary Outcome Measure:

  • Overall response

Secondary Outcome Measures:

  • Progression-free survival

  • Overall survival

Contact: Jeffrey S. Rose, MD • 614-366-8715 • Jeff.Rose@osumc.edu

ClinicalTrials.gov Identifier: NCT01129206

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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