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.
This feature highlights an NCCN study funded through the grant mechanism.
A 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 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 daily orally for 28 days (Cycle 0). Biopsies will be obtained pretreatment and 26 to 28 days after treatment initiation. After posttreatment biopsy and within 3 to 5 days of completing Cycle 0, patients will be initiated on combination therapy of enzalutamide, paclitaxel, and carboplatin.
Determine the clinical activity of combination enzalutamide/carboplatin/paclitaxel, represented as: