The National Cancer Institute’s steering committees review and prioritize concepts for large phase 2 or phase 3 clinical trials conducted in the National Clinical Trials Network, thus in large part driving the direction of new treatments. University of Colorado Cancer Center’s Associate Director for Clinical Research, Karyn Goodman, MD, MS, the David and Margaret Turley Grohne Chair in Clinical Cancer, was recently appointed co-chair of the NCI Gastrointestinal Cancer Steering Committee (GISC).
“As a radiation oncologist, I bring a different perspective to the group. I’m interested in applying what we’re learning with new treatment strategies in the metastatic setting, but also would like to focus on trials that evaluate these novel treatment strategies for localized disease in a curative setting,” Goodman says.
Goodman also represents the perspective of a non-coastal, NCI-designated cancer center, which serves patients from a much larger geographic area than counterparts in more densely populated parts of the country.
“We have to make sure that clinical research is feasible for our patients,” Goodman says, citing the need for clinical trial designs that take into account the difficulties of traveling for treatment, and the need to educate cancer patients about the possible benefits and importance of clinical trials.
Working under the umbrella of the GISC are task forces for GI cancer types including colon, gastric, pancreatic, esophageal and others. Generally, groups of cooperating oncologists such as the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, the Southwest Oncology Group, and the NRG Oncology Group, will propose clinical trial protocols to the NCI task force specific to the type of cancer being targeted. The task force will then narrow the field and present promising clinical trials to the appropriate NCI steering committee.
“The steering committee then assesses the strength of the clinical trial portfolio for that disease team and the trial’s alignment with the overall strategic priorities for the NCTN,” Goodman says.
Of course, not every clinical trial proposed by cooperative groups can be approved, primarily due to funding concerns. And so one major goal of NCI steering committees such as the GISC is to set the strategic priorities for clinical research in GI cancers and to make sure that each trial is furthering those goals. This includes ensuring that trials don’t accidentally duplicate efforts, while prioritizing trials of therapies with the most potential benefit. It also includes innovation in the design of clinical trials.
“One priority is to develop clinical trial designs so that we can identify populations who are mostly likely to benefit from a new therapy and have endpoints that are not going to require long follow up and thousands of patients, so that we can be more efficient and understand the benefits of new drugs as soon as possible,” Goodman says.
For example, instead of waiting for many years for data describing overall patient survival, some trials now use surrogate markers of a drug’s effect, such as examination of a tumor sample under a microscope. Goodman also points to trials in which the “backbone” of the trial’s design can be used to test many possible drugs.
“Another priority is to look for biomarkers that can help us predict which patients will see the most benefit from our trials,” Goodman says.
For example, Goodman is principal investigator of the clinical trial CALGB 80303, which uses PET scan to choose between two common chemotherapy regimens for colorectal cancer. Other biomarker-driven clinical trials test individual tumors for the genes driving the disease, and then match patients with targeted treatments designed against these genes.
“Now with targeted treatments and immunotherapies in addition to chemotherapy, surgery and radiation, the way we are treating cancer is changing. Our clinical trials have to change, too,” Goodman says. As co-chair of the NCI GISC, Goodman will be at the forefront of this change.