Dr. Benson Reflects on a Generation of GI Oncology Research  

Young Investigators Present Research at Fall Group Meeting

The ECOG-ACRIN Cancer Research Group is currently working in concert with the National Cancer Institute, Food and Drug Administration, and pharmaceutical companies on three randomized phase III trials designed for regulatory drug approval. The Breast Committee is investigating entinostat in metastatic breast cancer in E2112 (N=600 patients), which will open soon to patient enrollment. Entinostat is manufactured by Syndax. E2112 is the first phase III trial of epigenetic therapy in metastatic disease. The lead investigator for E2112 is Roisin Connolly, MB, BCh (Johns Hopkins University), a young investigator under the mentorship of Kathy D. Miller, MD (Indiana University), who chairs the Breast Committee. 

The Leukemia Committee is investigating ibrutinib, a small molecule inhibitor of Bruton's tyrosine kinase, in combination with rituximab in E1912 (N=519 patients), which is currently open to patient enrollment. E1912 will evaluate the ability of the ibrutinib-based therapy to prolong progression-free survival in patients with chronic lymphocytic leukemia, or CLL. Tait D. Shanafelt, MD (Mayo Clinic), a young investigator, is leading E1912 under the mentorship of Neil E. Kay, MD (Mayo Clinic). Ibrutinib is manufactured by Pharmacyclics.

The Leukemia Committee is also investigating blinatumomab, the first BiTEŽ antibody to be developed for the treatment of cancer, in E1910 (N=360 patients), also open to patient enrollment at this time. Blinatumomab is manufactured by Amgen. E1910 will compare overall survival after treatment with blinatumomab in combination with chemotherapy vs. chemotherapy alone in newly diagnosed patients with BCR-ACL-negative B-lineage acute lymphoblastic leukemia, or ALL. Mark R. Litzow, MD (Mayo Clinic) is the lead investigator for E1910. Ryan J. Mattison, MD (University of Wisconsin) is a young investigator co-leading the study under the mentorship of Dr. Litzow. Dr. Litzow also chairs the Leukemia Committee.

These trials are being conducted by ECOG-ACRIN under the sponsorship of the NCI. Patient recruitment will involve participation from SWOG, the Alliance for Clinical Trials in Oncology, and NRG Oncology, the three other network groups of the NCI National Clinical Trials Network that conduct cancer research in adults, like ECOG-ACRIN.

 

View the E1910 press release...

View the E1912 press release...

Protocol development activity was robust in recent months across the three ECOG-ACRIN scientific programs--Cancer Control, Therapeutic Studies, and Biomarker Sciences. As a result, 14 new trials have opened to patient enrollment since July 1, 2013. The wide array of scientific questions being explored in these trials reflects the group's expansive scientific aims. It also demonstrates the interactions across the 30+ committees and working groups involved--a cross-program integration that provides the members of ECOG-ACRIN with a dynamic multidisciplinary environment in which to pursue new scientific concepts. The 14 studies are listed below.

  

A Multi-Center Study Evaluating the Utility of Diffusion-Weighted Imaging for Detection and Diagnosis of Breast Cancer

Chair: Savannah Partridge, PhD (University of Washington)

Co-Chair: Habib Rahbar, MD (University of Washington)

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A Randomized, Double-Blinded, Placebo-Controlled Phase II Study of Adjuvant Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the Liver

Chair: Steven K. Libutti, MD (Albert Einstein College of Medicine)

Co-Chair: Pamela L. Kunz, MD (Stanford University)

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Phase II Randomized Trial of Transoral Surgical Resection followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

Chair: Robert L. Ferris, MD, PhD (University of Pittsburgh)

Co-Chair: Harry Quon, MD, MS (Johns Hopkins University)

A Randomized, Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence

Chair: Christine H. Chung, MD (Johns Hopkins University)

Co-Chair: Missak Haigentz, Jr., MD (Albert Einstein College of Medicine)

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A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B Lineage Acute Lymphoblastic Leukemia in Adults

Chair: Mark R. Litzow, MD (Mayo Clinic)

Co-Chair: Ryan J. Mattison, MD (University of Wisconsin)

A Randomized Phase III Study of Ibrutinib (PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia 

Chair: Tait Shanafelt, MD (Mayo Clinic)

Co-Chair: Neil E. Kay, MD (Mayo Clinic)

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Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma

Chair: Grzegorz S. Nowakowski, MD (Mayo Clinic)

Co-Chair: Thomas E. Witzig, MD (Mayo Clinic)

Phase II Randomized Trial Comparing GA101 (Obinutuzumab) and Rituximab in Patients with Previously Untreated Low Tumor Burden Indolent Non-Hodgkin Lymphoma

Chair: Stephen M. Ansell, MD, PhD (Mayo Clinic)

Co-Chair: Brad S. Kahl, MD (University of Wisconsin)

A Phase I Study with an Expansion Cohort of the Combination of Ipilimumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma

Chair: Catherine M. Diefenbach, MD (New York University)

Co-Chair: Stephen M. Ansell, MD, PhD (Mayo Clinic)