5-Fluorouracil (5-FU), folinic acid and irinotecan (FOLFIRI) versus 5-FU and folinic acid as second-line chemotherapy in patients with biliary tract cancer (IRIBIL): a randomized open-label phase 2 study

Phase 1

Active, not recruiting

• Conditions: biliary tract cancer not amedable for curative resection with progressive disease after first-line chematherapy with gemcitabine and cisplatin; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004028-69-DE
• Lead Sponsor: Goethe-Universität Frankfurt, PD Fabian Finkelmeier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-04
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Written informed consent granted prior to initiation of any study specific screening procedures
• Patients with histologically confirmed CCA or GB-CA not suitable for resection or metastatic
• Progressive disease undergoing a systemic chemotherapy with a platin-derivate (Oxaliplatin, Cisplatin or Carboplatin) or progressive disease within 3 months after cessation of chemotherapy
• Age >= 18 years
• Performance status ECOG 0-2
• Normal organ and bone marrow function defined as:
o Hematopoetic: absolute neutrophil count >1,500/mm3, platelet count >75,000/mm3, hemoglobin >9 g/dL
o INR = 1.5
o Hepatic: AST or ALT < 5 x ULN, bilirubin = 2 mg/dl
o Renal: serum creatinine < 1.5 x ULN
• Child Pugh stage A in patients with cirrhosis
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the randomization
• Male or female patients of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

• CCA or GB-CA amendable for surgical resection
• Prior radiation therapy, chemoradiation, transarterial chemoembolisation (TACE), Radiofrequency ablation (RFA) or selective intraarterial Radiotherapy (SIRT) within the last 3 months, radiation of symptomatic bone metastasis is allowed
• Concomitant photodynamic therapy or intraductal radiofrequency ablation within the last 8 weeks
• Child Pugh stage B or C (> 6 points) in patients with cirrhosis (Appendix 21.3)
• Massive, uncontrolled ascites
• Systemic anticancer chemotherapy other than Gemcitabin and a platin derivate (Cisplatin, Carboplatin or Oxaliplatin)
• Cardiac disease: congestive heart failure > class II NYHA
• Known uncontrolled brain metastasis
• History of bone marrow or organ allograft
• Active clinically serious infections > CTCAE grade 2 beside of chronic hepatitis C virus infection
• Major surgery within 4 weeks of first dose of study drug, port implantation is allowed
• Known or suspected allergies to 5-FU, folinic acid or irinotecan
• Previous cancer that is distinct in primary site or histology from CCA or GB-CA except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry
• Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study
• Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment
• Pregnancy or breast feeding women
• Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •Determination of the progression free survival (PFS) in FOLFIRI arm > 2 months;Secondary Objective: Determination of<br>•overall survival (OS)<br>•time to progression (TTP) by RECIST 1.1<br>•overall response rate (either complete response, CR, or partial response, as measured by RECIST 1.1<br>•safety profile<br>•quality of life (EORTC QLQ-C30 questionnaire)<br>;Primary end point(s): Determination of the progression free survival (PFS) in FOLFIRI arm > 2 months;Timepoint(s) of evaluation of this end point: every 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - overall survival (OS)<br>- time to progression (TTP) by RECIST 1.1<br>- overall response rate (either complete response, CR, or partial response, as measured by RECIST 1.1<br>- safety profile<br>- quality of life (EORTC QLQ-C30 questionnaire)<br>;Timepoint(s) of evaluation of this end point: - overall survival (OS): every visit<br>- time to progression (TTP) by RECIST 1.1: every 8 weeks<br>- overall response rate (either complete response, CR, or partial response, as measured by RECIST 1.1: every 8 weeks<br>- safety Profile: every visit<br>- quality of life (EORTC QLQ-C30 questionnaire): every 2 weeks<br>