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.
An NCCN study funded through the grant mechanism is highlighted below.
Phase II Study With a Limited Safety Lead-In of Enzalutamide in Combination With Carboplatin and Paclitaxel in Advanced-Stage or Recurrent Endometrioid Endometrial Cancer
Principal Investigator: Shannon Westin, MD, MPH
Condition: Endometrial cancer
Institution: The University of Texas MD Anderson Cancer Center
This is a single-arm, open-label, phase II study with a limited safety lead-in of the novel androgen receptor (AR) inhibitor enzalutamide in combination with paclitaxel and carboplatin in previously untreated patients with advanced-stage and recurrent endometrioid endometrial cancer. In the safety lead-in (part A), 6 patients will be treated with the combination of enzalutamide and standard intravenous carboplatin and paclitaxel. Patients on the phase II portion of study (part B) will undergo induction treatment with single-agent enzalutamide at 160 mg/d orally for 28 days (cycle 0). Biopsies will be obtained pretreatment and 26 to 28 days after treatment initiation. After the posttreatment biopsy and within 3 to 5 days of completing cycle 0, patients will be initiated on combination therapy of enzalutamide, paclitaxel, and carboplatin.
Primary Objectives:
Determine clinical activity of combination enzalutamide, carboplatin, and paclitaxel, represented as:
Objective tumor response (complete response + partial response)
Proportion of patients who survive progression-free for at least 6 months after initiating therapy
Quantify protein and phosphoprotein expression of AR and AR-response genes following enzalutamide treatment in match-paired pretreatment and posttreatment tumor biopsies
Determine safety and feasibility of daily enzalutamide given in combination with carboplatin and paclitaxel
Secondary Objectives:
Determine median response duration
Estimate progression-free and overall survivals
Evaluate for presence of pharmacokinetic interaction between enzalutamide and paclitaxel
Exploratory Objectives:
Correlate molecular results, including AR expression and activation, with clinical end points
Identify potential agents to synergize with enzalutamide based on pathways activated after enzalutamide treatment
Contact: Shannon Westin, MD, MPH • 713-794-4314 • swestin@mdanderson.org
Coordinator: Jeffry Cutrera, PhD • 713-745-6678 • jjcutrera@mdanderson.org
ClinicalTrials.gov Identifier: NCT02684227
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.
