Modified FOLFIRINOX + Pentamidine for Pancreatic Cancer
(FALCON Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug combination to determine if it can more effectively stop tumor growth in individuals with advanced pancreatic cancer. Participants will receive a standard treatment called modified FOLFIRINOX, with some also receiving an additional drug, pentamidine, an antimicrobial medication. The researchers aim to discover if adding pentamidine enhances the treatment's effectiveness. Individuals diagnosed with advanced or metastatic pancreatic cancer and possessing a tumor suitable for biopsy may qualify for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that modified FOLFIRINOX is generally safe for treating pancreatic cancer, though it can cause side effects. One serious side effect is neutropenia, a condition characterized by a low white blood cell count, which makes fighting infections more difficult. In one study, about 64.6% of patients experienced this side effect. Despite this, modified FOLFIRINOX is considered safer than the original version while remaining effective against pancreatic cancer.
Researchers are exploring the addition of pentamidine, a drug often used to treat certain infections, to modified FOLFIRINOX. Although specific safety data on this combination is limited, pentamidine has been used safely in other medical contexts. During the trial phase, researchers closely monitor how well participants tolerate the combination. While evidence supports the safety of each drug individually, the exact safety of using them together remains under study.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using modified FOLFIRINOX with Pentamidine for pancreatic cancer because it introduces a novel addition to the existing chemotherapy regimen. The standard of care typically involves FOLFIRINOX or gemcitabine-based treatments. This trial stands out as it combines the well-established modified FOLFIRINOX regimen with Pentamidine, an antifungal medication not traditionally used in this context. The hope is that Pentamidine may enhance the effectiveness of chemotherapy, potentially offering a new avenue for treating this challenging cancer.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
Research has shown that modified FOLFIRINOX effectively treats pancreatic cancer, often extending patient survival compared to gemcitabine. One study found that patients lived a median of 54.4 months with modified FOLFIRINOX, nearly 20 months longer than with gemcitabine. Patients also experienced longer periods without cancer progression. In this trial, one group will receive modified FOLFIRINOX alone, while another group will receive it combined with pentamidine to evaluate if this combination enhances effectiveness. More information on this combination is still being gathered.678910
Who Is on the Research Team?
Susanna Ulahannan, MD
Principal Investigator
University of Oklahoma
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic pancreatic or biliary tract cancer. Participants should be healthy enough to receive chemotherapy and not have other serious health problems that could interfere with treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive modified FOLFIRINOX every two weeks for 8 cycles, with or without Pentamidine, depending on the arm
Biopsy and Additional Treatment
After 8 cycles, patients undergo EUS core biopsy and additional blood draw, followed by continued treatment per physician's discretion for up to 4 more cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- modified FOLFIRINOX
- Pentamidine
Trial Overview
The study is testing a combination of modified FOLFIRINOX (a standard chemotherapy regimen) and pentamidine injections to see if this new mix can better control tumor growth in these cancers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
In arm B patients (up to 15), the same modified FOLFIRINOX regimen will be used, as above, plus 300 mg pentamidine will be administered IV over a one-hour infusion on Day 1 of each cycle. Patients will be treated over eight two-week cycles, and the entire treatment is expected to last approximately 4 months.
In Arm A (up to 15 patients) will be treated with modified FOLFIRINOX every two weeks, delivered as follows: * Oxaliplatin 85mg/m2 IV over 2 hours on Day 1, followed by, * Irinotecan 150mg/m2 IV over 90 minutes on Day 1, followed by * Leucovorin 400mg/m2 IV over 2 hours on Day 1, followed by * 5FU 2400mg/m2 IV over 46-48 hours on Days 1-3 Patients will be treated over eight two-week cycles, and the entire treatment is expected to last approximately 4 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor
Citations
Real-world dose reduction of standard and modified ... - PMC
Severe neutropenia is associated with better clinical outcomes in patients with advanced pancreatic cancer who receive modified FOLFIRINOX therapy. Cancers ( ...
Clinical outcomes for modified FOLFIRINOX chemotherapy ...
Conclusion: Metastatic pancreatic cancer patients treated with mFOLFIRINOX showed increased survival compared to gemcitabine plus nab-paclitaxel, with a similar.
3.
mdanderson.org
mdanderson.org/newsroom/preoperative-combination-chemotherapy-improved-survival-in-patients-with-pancreatic-cancer.h00-159541323.htmlPreoperative combination chemotherapy improved survival ...
The patients receiving neoadjuvant modified FOLFIRINOX had an 18-month overall survival (OS) rate of 66.7%, exceeding both the preselected ...
The efficacy and safety of modified FOLFIRINOX as first-line ...
The estimated median overall survival and progression-free survival were 11.60 (95% confidence interval [CI] 8.76–14.44) and 5.77 (95% CI 5.00– ...
5.
2minutemedicine.com
2minutemedicine.com/modified-folfirinox-results-in-longer-disease-free-survival-in-metastatic-pancreatic-cancer-patients-compared-to-gemcitabine/Modified FOLFIRINOX results in longer disease-free ...
Modified FOLFIRINOX results in longer disease-free survival in metastatic pancreatic cancer patients compared to gemcitabine · Go deeper into the ...
Asynchronous evolution of epithelium and stroma ... - PubMed
Together, our data show asynchronous evolution of epithelial and stromal components during pancreatic carcinogenesis. Lack of stromal ...
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