The University of Colorado Cancer Center and The University of Texas MD Anderson Cancer Center were recently awarded a competitive $4.25 million, five-year grant (U01 CA099176) by the National Cancer Institute (NCI) to support early therapeutics clinical trials. As one of 12 NCI’s Early Therapeutics Clinical Trials Network sites, the collaboration will work to define better approaches to the development of novel anticancer agents and conduct phase I clinical trials for drugs sponsored by the NCI’s Cancer Therapy Evaluation Program.
The grant is CU Cancer Center’s first UM1 cooperative agreement from the NCI, and is the first time the southwestern United States has been represented in the early clinical trials program. The CU Cancer Center and MD Anderson site, called the Southwest Early Clinical Trials (SECT) Consortium, will be led by three principal investigators: James C. Yao, MD, deputy chair of Gastrointestinal Medical Oncology at MD Anderson; Funda Meric-Bernstam, MD, chair of Investigational Cancer Therapeutics at MD Anderson; and S. Gail Eckhardt, MD, co-head of the Division of Medical Oncology and senior associate director of translational and collaborative research at CU Cancer Center.
“Increasingly, the goal of the NCI and Cancer Center Program is to diversify our patient base. By partnering with institutions like MD Anderson we can meld our research expertise and diversify our patient populations enrolled in early phase clinical trials,” says Eckhardt. “This grant will continue to build and advance our existing research collaborations in gastrointestinal and bladder cancers.”
The new award transforms the previous NCI-sponsored cooperative experimental therapeutics clinical trials program from a series of separate organizations conducting trials into a consolidated and integrated network allowing each site to capitalize on the expertise within their centers. The sites will be able to rapidly take advantage of new scientific opportunities to promote therapeutic innovations that are generally not addressed in the private sector.
Drs. Yao and Meric-Bernstam’s expertise in clinical trial design and molecular biomarkers, and strong phase I clinical trials infrastructure at MD Anderson and CU Cancer Center, will enable the SECT to conduct high quality hypothesis-driven clinical research at a national level.
The ultimate purpose of the new network is to define better approaches to the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly and find appropriate biomarkers to select patients most likely to respond to specific agents. The clinical trials to be conducted by the network are intended to provide the dose, schedule and early evidence of activity that will help guide disease-specific clinical trials to be conducted by the National Clinical Trials Network.
“Phase I clinical trials allow patients to have earlier access to drugs, but it’s not only about early access,” Eckhardt says. “Through genetic sequencing we now know which patients are more likely to respond to targeted therapies and potentially which ones will have the best clinical benefit.”