Liposomal Irinotecan + FOLFOX for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byNelson Yee

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Nelson Yee

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC).

Eligibility Criteria

This trial is for adults with untreated locally advanced pancreatic cancer that's not suitable for surgery. Participants must have good liver, kidney, and blood function, no severe neuropathy or heart issues, and not be pregnant or breastfeeding. They should understand the study and agree to use two forms of contraception if they can have children.

Inclusion Criteria

- Hematological: Absolute Neutrophil Count (ANC): >/=1500/uL, Hemoglobin (Hgb): >/=8 g/dL with blood transfusion permitted, Platelet (Plt): >/=100,000/uL

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

I am 18 years old or older.

+10 more

Exclusion Criteria

I don't have any other cancer needing treatment in the last 2 years, except for minor skin cancers or cancers that have been inactive for 5+ years.

I am taking medications that cannot be changed and are not allowed in this study.

I do not have an ongoing serious infection.

+8 more

Participant Groups

The study tests a combination therapy (FOLFOX-nal-IRI) involving liposomal irinotecan with oxaliplatin, leucovorin, and 5-fluorouracil in patients with advanced pancreatic cancer. It aims to assess how effective and tolerable this regimen is as a treatment option.

1Treatment groups

Experimental Treatment

Group I: FOLFOX + IrinotecanExperimental Treatment2 Interventions

Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle.

FOLFOX regimen is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as FOLFOX for: