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Pancreatic Cancer | Proton w/FOLFIRINOX-Losartan for Pancreatic Cancer

Pancreatic Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Cytologic or histologic proof pancreatic ductal carcinoma - Locally advanced, unresectable disease - Life expectancy of at least 3 months Exclusion Criteria: - Evidence of metastatic disease - Pregnant or breastfeeding - Serious concomitant systemic disorders incompatible with the study - Already treated on ACE or ARB therapy for hypertension or renal protection at the time of enrollment - Baseline hypotension - Prior chemotherapy, radiation therapy, or biologic therapy for treatment of pancreatic tumor - Treatment for other invasive carcinomas within the last 5 years who are greater than 5% risk of recurrence at the time of eligibility screening (carcinoma in-situ and basal cell carcinoma/squamous cell carcinoma of the skin are allowed) - Other serious uncontrolled medical conditions - Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome - Known, existing coagulopathy - Prior systemic fluoropyrimidine therapy - Participation in any investigational drug study within 4 weeks preceding the start of study treatment - History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance or oral drug intake - Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment - Taking cimetidine - Receiving other study agents - History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, irinotecan, oxaliplatin or losartan

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pancreatic Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:FOLFIRINOXOxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes

Drug:LosartanTaken orally every day during Phase I for all 8 cycles

Radiation:Proton Beam Radiation30-45 minutes per day, daily Monday-Friday

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Experimental ArmFOLFIRINOX, Losartan, Proton Beam Radiation Therapy

Study Status

Recruiting

Start Date: July 2013

Completed Date: January 2019

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Feasibility of combining FOLFIRINOX-Losartan

Secondary Outcome: Progression-Free Survival

Study sponsors, principal investigator, and references

Principal Investigator: Theodore Hong, MD

Lead Sponsor: Massachusetts General Hospital

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT01821729

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