Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT07829185
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • modified FOLFIRINOX — DRUG
    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
  • Pentamidine 300 MG Injection — DRUG
    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.

Study Details

The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth.

Key Dates

First listed
Sep 18, 2026
Start date
Dec 31, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: modified FOLFIRINOX
    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.
  • Experimental: modified FOLFIRINOX + Pentamidine
    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.

Primary Outcome Measure

Number and proportion of patients with Grade 3 and higher adverse events deemed related to pentamidine during trial treatment, using CTCAE v.6.0. [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health CampusOklahoma CityOklahoma73104
Susanna Ulahannan, MD
[email protected]
572-244-0111

Find similar trials in Oklahoma City, OK

By research site
University of Oklahoma Health Campus· Oklahoma City, OK

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