A randomized Phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy
- Conditions
- pancreatic cancer10017991
- Registration Number
- NL-OMON55645
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Able to understand and provide written informed consent
>= 18 years of age
Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
Documented metastatic disease
Previously treated with gemcitabine or gemcitabine containing therapy, or
progression within 6 months of adjuvant gemcitabine treatment
Adequate hepatic, renal and hematological function
WHO 0-1
Any clinically significant gastrointestinal disorder, including hepatic
disorders, bleeding, inflammation, occlusion, or diarrhea > grade 2
Severe arterial thromboembolic events (myocardial infarction, unstable angina
pectoris, stroke) in last 6 months
NYHA Class III or IV congestive heart failure, ventricular arrhythmias or
uncontrolled blood pressure. Or known abnormal ECG with clinically significant
abnormal findings
Active infection or an unexplained fever >38.5°C (excluding tumor fever), which
in the physician*s opinion might compromise the patient*s health
Current use or any use in last two weeks of strong CYP3A-enzyme
inducers/inhibitors and/or strong UGT1A inhibitors
Known hypersensitivity to any of the components of liposomal irinotecan
(nal-IRI) other liposomal irinotecan formulations, irinotecan,
fluoropyrimidines, or leucovorin.
Hypersensitivity to any of the active substances (tegafur, gimeracil, and
oteracil)
Previous treatment with fluoropyrimidine therapy
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness
to use a reliable method of birth control, during therapy and for 3 months
following the last dose of liposomal irinotecan (nal-IRI).
Treatment within 4 weeks with DPD inhibitors, including sorivudine or its
chemically related analogues such as brivudine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose (MTD) of<br /><br>nal-IRI when co-administered with fixed dose S1 in patients with metastatic<br /><br>pancreatic cancer.<br /><br>Phase II part: Efficacy between the treatment arms in terms of progression free<br /><br>survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival<br /><br>Response rate according to RECIST 1.1<br /><br>Adverse events according to NCI CTC version 4.0<br /><br>Quality of life</p><br>