Health TrialsbyHealthPanel

Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer

ConditionPancreatic Ductal Adenocarcinoma (PDAC)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: modified FOLFIRINOXActive comparator 1 intervention
Group B: modified FOLFIRINOX + PentamidineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

To evaluate the safety in patients with metastatic or nonresectable locally advanced pancreatic cancer treated with modified FOLFIRINOX (arm A) versus modified FOLFIRINOX plus Pentamidine (arm B)

Time frame
3 years

Secondary outcomes

1

Evaluation of the objective response rate in modified FOLFIRINOX (arm A) versus modified FOLFIRINOX plus Pentamidine (arm B)

Proportion of patients with Objective response rate and partial response as measured by RECIST version 1.1 to be evaluated by imaging study and radiology review.

Time frame
3 years
2

Evaluation of the rate of progression-free survival in both arms

Proportion of patients with a response rate measurement of Progression-free survival determined by the number of days from the start of study treatment to date of imaging-confirmed tumor progression, death or last time of follow up

Time frame
3 years
3

Evaluation of the duration of response in both arms

Proportion of patients with Duration of response determined as the number of days from the onset of the first response to disease progression or death

Time frame
3 years
4

Evaluation of genetic mutations that predict patient response to modified FOLFIRINOX plus Pentamidine

Proportion of patients with expression levels of MUC1, SAT1, and other metabolic genes by performing transcriptomic analysis of biopsies.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: