Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX

Phase 2

Recruiting

• Conditions: Metastatic pancreatic cancer

• Registration Number: JPRN-UMIN000017538
• Lead Sponsor: ational Cancer Center Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1)Prior radiotherapy or chemotherapy 2)Grade 2 or greater peripheral neuropathy 3)Blood transfusion, administration of blood products, or hematopoietic (e.g., G-CSF) support within 7 days before enrollment 4)UGT genetic polymorphisms of homozygous UGT1A1*6 or UGT1A1*28 or heterozygous UGT1A1*6 and *28 5)confirm the presence of ascites or peritoneal metastasis by imaging 6)Intestinal pneumonitis or pulmonary fibrosis 7)severe diarrhea within 3 days before enrollment 8)Clinically significant heart disease 9)Active infection (except HBV+,HCV+) 10)Poor glycemic control diabetes mellitus 11)Serious complications (organ failure, or active peptic ulcer etc) 12)Severe mental disorder, or central nervous system disorders 13)Serious drug allergy 14)Active double cancer 15)Brain or meningeal metastasis 16)Pregnancy 17)Treatment with atazanavir sulfate 18)Inappropriate for this study judged by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of febrile neutropenia during the first 3 cycles of treatment

Secondary Outcome Measures

Name	Time	Method
Overall Survival, Progression Free Survival, Response Rate, Relative Dose Intensity, Adverse events, Severe adverse events