EUCTR2018-002936-26-DE
Active, not recruiting
Phase 1
Efficacy and safety of Trifluridine/Tipiracil in combination with Irinotecan as a second line therapy in patients with Cholangiocarcinoma - TRITICC
Heinrich-Heine-University Düsseldorf0 sites28 target enrollmentDecember 17, 2018
ConditionsPatients with advanced, non resectable or metastatic cholangio- and gallbladder carcinoma after failure to respond to a previous gemcitabine treatment.Therapeutic area: Diseases [C] - Cancer [C04]
DrugsLonsurf
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with advanced, non resectable or metastatic cholangio- and gallbladder carcinoma after failure to respond to a previous gemcitabine treatment.
- Sponsor
- Heinrich-Heine-University Düsseldorf
- Enrollment
- 28
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Written informed consent incl. participation in translational research and any locally\-required authorization (EU Data Privacy Directive in the EU) prior to performing any protocol\-related procedures, including screening evaluations
- •2\.Age \= 18 years at time of study entry
- •3\.Histologically or cytologically confirmed, non\-resectable, locally advanced or metastatic cholangiocarcinoma or gall bladder carcinoma
- •4\.Measurable or assessable disease according to RECIST 1\.1
- •5\.Documented disease progression after prior gemcitabine or gemcitabine containing therapy. Examples of permitted therapies include, but are not limited to: a) Single agent gemcitabine); b) Any gemcitabine\-based regimen, with or without maintenance gemcitabine
- •6\.ECOG performance status 0\-1
- •7\.Ability to take medications orally
- •8\.Adequate blood count, liver\-enzymes, and renal function:
- •\- ANC \> 1,500 cells/µL without the use of hematopoietic growth factors; and Platelet count \= 100 x 109/L (\>100,000 per mm3\) and Hemoglobin \> 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL)
- •\- Serum total bilirubin \= 1\.5x upper normal limit (ULN) (biliary drainage is allowed for biliary obstruction; elevated bilirubin should be caused by obstruction not impaired liver function as assessed by albumin and INR values):
Exclusion Criteria
- •1\.Age \< 18 years
- •2\.CNS metastases
- •3\.Active, uncontrolled infection
- •4\.Additional malignancy within the past 2 years (except adequately treated in\-situ carcinoma of the cervix or non\-melanoma skin cancer)
- •5\.Clinically significant gastrointestinal disorders including bleeding, inflammation, occlusion, or diarrhea \> grade 1
- •6\.Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- •7\.Known hypersensitivity to Trifluridine/Tipiracil or CPT\-11 or their components
- •8\.Medication that is known to interfere with any of the agents applied in the trial
- •9\.Pregnancy or lactating female
- •10\.Prior partial or total gastrectomy
Outcomes
Primary Outcomes
Not specified
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