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biweekly irinotecan monotherapy for refractory advanced pancreatic cancer

biweekly irinotecan monotherapy for refractory advanced pancreatic cancer - biweekly irinotecan monotherapy for refractory advanced pancreatic cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009739
Enrollment
53
Registered
2013-01-10
Start date
2013-01-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced pancreatic cancer refractory to chemotherapy

Interventions

irinotecan div day 1 and 15 in a 4-week course

Sponsors

The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with advanced or recurrent pancreatic cancer 2) Patients with pathologically confirmed pancreatic cancer 3) Patients refractory to gemcitabine and S-1 4) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 5) Patients of age >= 20 years 6) Patients have an adequate organ function 6) Patients have an ability for a sufficient oral intake 7) Written informed consent is required from all patients

Exclusion criteria

Exclusion criteria: 1) Patients with active infection 2) Patients with active GI bleeding 3) Patients with intestinal pneumonia, pulmonary fibrosis, and severe pulmonary emphysema 4) Patients with uncontrolled pleural effusion or ascites 5) Patients with watery diarrhea or ileus 6) Patients with synchronous or metachronous concomitant malignancies 7) Pregnant or lactating female or patients who are considering pregnancy 8) Patients with contraindication to irinotecan 9) Patients who are actively on other anticancer treatment 10) Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
response rate, disease control rate, progression free survival, 1-year survival rate, adverse events

Countries

Japan

Contacts

Public ContactHiroyuki Isayama

The University of Tokyo Department of Gastroenterology, Graduate School of Medicine

isayama-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026