September 25, 2020:

Researchers at Penn State University are leading a multi-center phase II Big Ten Cancer Research Consortium study for adults with previously untreated, locally advanced pancreatic cancer that tests liposomal irinotecan in combination with FOLFOX, a chemotherapy regimen that includes oxaliplatin, leucovorin, and 5-fluorouracil.

Researchers hope to determine the disease control rate of this combination — the percentage of patients whose tumors respond to treatment or remain stable. The study could help determine if this novel approach could be used as a first-line treatment for locally advanced pancreatic cancer.

Liposomal irinotecan uses a tiny bubble called a liposome that is made of the same material as a cell wall. The liposome is filled with a drug called irinotecan that will circulate through a subject’s body for an extended period, which may result in a longer treatment effect and may help minimize harmful side effects of the drug on healthy tissue.

The study, titled “A phase II study to evaluate the efficacy of liposomal irinotecan in combination with oxaliplatin, leucovorin, and 5-fluorouracil for patients with locally advanced pancreatic carcinoma: Big Ten Cancer Research Consortium BTCRC-GI15-067,” is open to accrual at Penn State Cancer Institute.

“This is going to be a collaboration of several institutions within the Big Ten Cancer Research Consortium,” said Nelson S. Yee, MD, PhD, RPh, a medical oncologist at Penn State Cancer Institute and sponsor-investigator of the study.

Pancreatic cancer is considered a relatively rare type of cancer with more than 56,000 new cases estimated in the United States in 2019. Yet, this type of cancer is the third leading cause of cancer death in the U.S., and there are currently no established diagnostic tools for early detection.

People with locally advanced pancreatic cancer are typically treated with chemotherapy for six months, sometimes followed by chemoradiation if the cancer has not spread outside the pancreas. On rare occasions, the cancer can be surgically removed when there is a significant downsizing of the tumor; otherwise, patients whose tumors are not growing may receive further chemotherapy or undergo observation.

“The standard is still gemcitabine, but currently chemotherapy includes the regimen FOLFIRINOX,” Dr. Yee said. This regimen combines leucovorin, fluorouracil, irinotecan, and oxaliplatin.

Liposomal irinotecan in combination with fluorouracil and leucovorin is approved by the U.S. Food and Drug Administration (FDA) to treat patients with advanced pancreatic cancer after prior treatment with gemcitabine.

The combination of liposomal irinotecan with FOLFOX to treat patients with previously untreated locally advanced pancreatic cancer has not been approved by the FDA and should be considered investigational.

“By using a liposome as vessel to carry a higher concentration of irinotecan within the tumor cells, the anti-cancer effect will be greater than the traditional irinotecan,” Dr. Yee said.

Up to 28 participants may enroll in the study. All subjects will receive the same combination of liposomal irinotecan and FOLFOX.

Treatment will be administered in cycles, with each cycle lasting 14 days. Each drug will be given to subjects intravenously on Day 1 of each cycle. Treatment may continue until surgical resection, disease progression, patient/physician decision, completion of 12 cycles, or patient withdrawal from the study.

In addition to the study’s primary objective — disease control rate — the study will assess objective response rate, stable disease rate, the rate of tumor resection, progression-free survival, overall survival, safety and tolerability, quality of life, and other measures.

Tissue and blood will be collected to support correlative research and banking for future research.

“One of the correlative objectives is to examine the molecular profiles of the tumor and correlate it with the efficacy of the treatment, and also to determine the treatment-induced DNA damage and apoptosis in the tumor and correlate with the efficacy of the treatment,” Dr. Yee said.

Researchers also will correlate tumor molecular profiles with the efficacy of the treatment, Dr. Yee said.

To participate in this clinical trial, subjects must be adults ages 18 and older with previously untreated, locally advanced, unresectable pancreatic cancer. Other criteria must be met to enroll in the study.

The study is supported by Ipsen Biopharmaceutics.

For more information about this research study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT03861702).

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 more than 9,800 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.