May 2, 2018:

A Big Ten Cancer Research Consortium study, led by investigators at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, could help determine whether an investigational combination of chemotherapy drugs might lead to improved overall responses in patients with metastatic or advanced unresectable gastric/gastroesophageal junction cancer.

The goal of the single-arm, phase II study, known as BTCRC-GI15-015, is to estimate the overall objective response rate in subjects receiving the combination of FOLFOX and nab-paclitaxel (FOLFOX-A).

In the United States, about two-thirds of patients who are diagnosed with localized gastric cancer are still alive after 5 years. Yet, the majority of patients with gastric cancer are diagnosed when their disease has already spread to regional lymph nodes or to distant part of the body. Only about 5 percent of patients with metastatic disease are alive after 5 years.

Combination therapies often produce slightly longer response rates than single-agent therapies in gastric cancer. However, there is no consensus on the best regimen for initial therapy for advanced gastric cancer. Many of the current standard therapies, such as cisplatin-based agents, produce toxicities that can significantly impact a patient’s quality of life.

FOLFOX is a combination of drugs that includes folinic acid, fluorouracil (5FU), and oxaliplatin. BTCRC-GI15-015 researchers noted that FOLFOX may be at least as effective as cisplatin for patients with advanced gastric cancer with potentially fewer reported instances of certain adverse events.

Nab-paclitaxel has been shown to be an effective agent for combination therapy in pancreatic cancer. BTCRC-GI15-015 investigators are now testing whether it might be an effective agent for use in combination therapies for gastric cancer.

The study is now open to enrollment. The study will enroll about 39 subjects.

This trial is supported by Celgene Corporation.

For more information about this study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT03283761).

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to almost 9,500 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit www.bigten.org.