Proton w/FOLFIRINOX-Losartan for Pancreatic Cancer
Status:
Active, not recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
This is a Phase II clinical trial, which tests the safety and effectiveness of an
investigational combination of drugs to learn whether the combination of drugs works in
treating a specific cancer. "Investigational" means that the combination of drugs is being
studied. It also means that the FDA has not yet approved it for your type of cancer. Proton
beam radiation therapy is an FDA approved radiation delivery system.
Conventional radiation therapy uses photons to treat cancer before patients undergo surgery
to remove the tumor. In this study we are using radiation with protons, which spares
surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area
requiring radiation with no dose beyond the treatment area. This may reduce side effects that
patients would normally experience with conventional radiation therapy.
Researchers in the laboratory have discovered pathways inside cancer cells which contribute
to the growth and survival of tumors. The FOLFIRINOX chemotherapy regimen is a combination of
the drugs 5-fluorouracil, leucovorin and oxaliplatin. These chemotherapy drugs, along with
the chemotherapy drug capecitabine, work by blocking these pathways and thereby preventing
tumor growth. Capecitabine is FDA approved to be used alone or with other drugs to treat
other types of advanced cancer, but not pancreatic cancer. In past research studies,
FOLFIRINOX followed by radiation therapy with capecitabine has been identified as the most
effective and active chemotherapy for patients with cancer that is spreading, and this is why
we are using it to treat your type of cancer.
Losartan is classified as an angiotensin-receptor blocker (ARB), and is FDA approved for use
in people with high blood pressure. Recent studies in people with different types of cancer,
including pancreatic cancer, have shown that combining chemotherapy drugs with an ARB can
help reduce/stop tumor growth more effectively than chemotherapy alone. Losartan has been
used in previous research studies, and information from those research studies suggests that
this drug in combination with FOLFIRINOX and capecitabine may be better at treating your type
of cancer.
In this research study, we seek to determine whether combining FOLFIRINOX with Losartan
before proton radiation therapy will be more efficient at controlling the growth of or
shrinking your tumor than just FOLFIRINOX alone.