University of Oklahoma
The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth.
The patients will undergo testing, exams, and procedures per the Protocol. On study, patients will be randomized into one of the two arms. 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 In arm B patients (up to 15), the same modified FOLFIRINOX regimen will be used, as above, plus 300 mg pentamidine wil…
Inclusion Criteria: * Written informed consent signed and dated by the patient * At least 18 years-of-age at the time of signature of the informed consent form (ICF) * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Patients with a confirmed diagnosis of locally advanced, unresectable and/or metastatic pancreatic cancer * Patients must have at least one measurable disease per RECIST v1.1, * Patients must have at least 1 tumor lesion amenable to biopsy and must be willing to undergo a biopsy prior to first treatment and after receiving 8th cycle of therapy. * Ade…
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
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.
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