Modified FOLFIRINOX with Pentamidine in Advanced Pancreatic Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial randomizes participants to receive a twice-weekly modified FOLFIRINOX regimen alone or with the addition of pentamidine, administered on day 1 of each cycle. Treatment continues for up to 8 cycles (about 4 months) before a biopsy and blood collection to study translational endpoints, with up to 4 additional cycles or 2 months of follow-up for progression or toxicity. Eligibility includes adults with measurable, unresectable or metastatic PDAC, adequate organ function, and a performance status of 0–1. Outcomes focus on safety, tolerability, and preliminary signals of response to the combination therapy.

Why it matters

Who can join: the full rules

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.
* Adequate bone marrow function defined as ANC\> 1000/μL and platelets\>75,000/μL
* Adequate liver function defined as total bilirubin\<1.5g/L
* Adequate renal function defined as creatinine \<1.5ULN or creatinine clearance greater than 30 ml/m2.
* AST and ALT \<2.5x ULN or AST and ALT\<5xULN if liver function abnormalities are due to liver metastases
* Male or female patients. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following the last dose. Male patients must also refrain from donating sperm during their participation in the study.
* Life expectancy ≥ 3 months according to the Investigator's judgment.

Exclusion Criteria:

* Any systemic anti-cancer chemotherapy, small molecule, biologic, or from a previous treatment regimen or clinical study in a metastatic setting before the first dose of study drug.
* Active bacterial infection
* Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of study treatment
* Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment
* Any of the following cardiac criteria currently or within the last 6 months:

  1. Mean resting corrected QT interval (QTc) \>480 msec
  2. Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block
  3. Congestive heart failure (New York Heart Association ≥ Grade 2
  4. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
* Incidences of chronic hypokalemia that cannot be corrected.
* As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection requiring treatment including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
* Presence of other active invasive cancers other than the one treated in this study within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
* Prisoners

Where it's running

• University of Oklahoma Health Campus
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Susanna Ulahannan, MD — University of Oklahoma
• Study coordinator: Marisha Williams
• Email: SCC-IIT-Office@ouhsc.edu
• Phone: 572-244-0111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.