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
- Conditions
- C22C23Malignant neoplasm of liver and intrahepatic bile ductsMalignant neoplasm of gallbladder
- Registration Number
- DRKS00012595
- Lead Sponsor
- Dekanat des Fachbereichs MedizinUniversitätsklinikum der Goethe-Universität Frankfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
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 after undergoing a systemic chemotherapy with a platin-derivate (Oxaliplatin, Cisplatin or Carboplatin) and Gemcitabine 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 (Appendix 21.2)
- 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 oral contraception, intrauterine device, bilateral tubal occlusion, vasectomised partner or avoidance of intercourse during the study and for 180 days after last investigational drug dose received
- 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
- 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, irinotecan or other constituent materials or a known dihydropyrimidin-dehydrogenase deficiency
- 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
- Concomitant treatment with Brivudin, Sorivudin or their analogues or use of St. John's wort
- severe diarrhea
- inflammatory bowel disease and/or ileus
- - concomitant use of live attenuated vaccines during and 6 months after the end of chemotherapy
- Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of the progression free survival (PFS) in FOLFIRI Arm is longer than 2 months<br>Treatment will be continued until one of the following occurs:<br>- progressive disease (PD),<br>- not tolerable toxicity <br>- patient’s wish,<br>- other reasons according to which continuation of treatment is not in the patient’s best interest<br>
- Secondary Outcome Measures
Name Time Method Determination of<br>- overall survival (OS)<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<br>- safety profile<br>- quality of life (EORTC QLQ-C30 questionnaire), every 2 weeks<br>