A randomized phase II study comparing liposomal irinotecan + fluorouracil + levofolinate to FOLFIRINOX as second-line chemotherapy for pancreatic cancer (NUPAT-09 trial)

Phase 2

Recruiting

• Conditions: Pancreatic cancer; D021441

• Registration Number: JPRN-jRCT1041200082
• Lead Sponsor: Maeda Osamu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Advanced or recurrent pancreatic cancer treated with primary chemotherapy including gemcitabine
2. ECOG performance status 0 or 1
3. Neutrophil count >= 2,000/mm3
4. Platelet count >= 100,000/mm3
5. Total bilirubin >= upper limit of normal x 1.5

Exclusion Criteria

1. Complications of infectious diseases
2. Serious cardiac disease or a history of such disease
3. Intestinal paralysis or intestinal obstruction
4. Interstitial pneumonia or pulmonary fibrosis
5. Massive ascites or pleural effusions
6. Severe dysesthesia or sensory deficiency with functional impairment
7. A history of hypersensitivity to oxaliplatin or other platinum-containing drugs, irinotecan, liposomal irinotecan, fluorouracil, or levofolinate.
8. Pregnant women or women who may be pregnant
9. Patients on atazanavir sulfate

Study & Design

• Study Type: Interventional
• Study Design: Not specified