Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis

Korábbi kezelés

• Prior treatment of pancreatic cancer in the metastatic setting with surgery or investigational therapy (Note: biliary drainage, diagnostic laparoscopy/laparotomy, and duodenal stenting is allowed).
• Known disease progression with any prior chemotherapy.
• Current use of strong CYP2C8 inhibitors or inducers, or presence of any other contraindications for paclitaxel.
• Has ever received or is currently receiving radiation for pancreatic cancer treatment.
• Receipt of live, attenuated vaccine within 30 days prior the first dose of Intraperitoneal paclitaxel. (Note: enrolled patients should not receive live vaccines during the study and up to 30 days after the last dose of intraperitoneal paclitaxel).
• Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy within 7 days prior to C1D1. Both male and female patients of reproductive potential must agree to use a highly effective method of birth control during the study and for 9 months following the last dose of both IP PTX and IV NALIRIFOX.

Más betegség

• Evident distant metastatic disease outside of the peritoneal cavity.
• Extensive metastatic disease in peritoneal cavity (PCI>8).
• Known hypersensitivity to paclitaxel or other liposomal products.
• Known active COVID infection with symptoms.
• Known positive test results for human immunodeficiency (HIV) or patients with chronic or active hepatitis B or C. Patients who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
• Active infection during screening visits or on the day of treatment, which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome.
• Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
• Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.

Egyéb

• Known UGT1A1 deficiency or DPD deficiency.
• Neuropathy Grade 2 or higher
• Histologies other than adenocarcinoma, such as neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.

• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Be age 18 years or older.
• Histologically or cytologically confirmed pancreatic adenocarcinoma with histologically or cytologically proven seeding in the peritoneal cavity without metastasis to other organs.
• Primary tumor that is resectable, borderline resectable, or locally advanced per NCCN classification.
• PCI score ≤ 8.
• ECOG performance status of 0 or 1
• Prior treatment for 0-64 months with FOLFIRINOX, modified FOLFIRINOX, or NALIRIFOX and able to receive additional platinum-based treatment per investigator opinion
• Adequate biological parameters as evidenced by all of the following blood counts:
  • Absolute neutrophil count (ANC) >/= 1,500 per cubic millimeter without the use of hematopoietic growth factors within 14 days prior to screening
  • Platelet count >/= 75,000 per cubic millimeter
  • Hemoglobin > 9 g/dL
• Adequate hepatic function as evidenced by:
  • Serum total bilirubin ≤ 1.5x ULN (biliary drainage is allowed for biliary obstruction), and
  • AST and ALT ≤ 3 x ULN
• Adequate renal function as evidenced by serum creatinine <1.5 x ULN