unresecable, metastatic or recurrent cholangiocarcinoma (intrahepatic cholangiocellular carcinoma, bile duct cancer, gall bladder carcinoma) MedDRA version: 18.1 Level: LLT Classification code 10008594 Term: Cholangiocarcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Abraxane (nab-Paclitaxel)
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
University Hospital Essen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? signed informed consent before start of specific protocol procedure ? age > 18 years ? histologically or cytologically documented diagnosis of cholangiocellular carcinoma, bile duct cancer or gall bladder carcinoma ? presence of at least one measurable site of disease following RECIST 1.1 criteria ? unresecable, metastatic or recurrent disease ? ECOG performance 0 or 1 ? life expectancy of at least 3 months ? any contraindication for Cisplatin, i.e. renal impairment (creatinine clearance =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: ? no prior anti-cancer chemotherapy or radiotherapy for metastatic, advanced or recurrent disease; adjuvant/additive chemotherapy or radiotherapy after resection is allowed if therapy free intervall is at least 4 months; concomitant small volume palliative radiotherapy of bone metastases are allowed ? investigational drug therapy during or within 4 weeks of study entry ? major surgery within 4 weeks of starting therapy within this study ? symptomatic brain metastasis ? clincially significant cardiovascular disease (incl. Myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment ? active clinically serious infections (> grade 2 NCI-CTC version 4.0) ? history of interstitial lung disease ? liver cirrhosis child-pugh score > 8 ? history of HIV infection or chronic hepatitis B or C ? pre-exisiting neuropathy > grade 1 (NCI-CTC version 4.0) ? patients with evidence of bleeding diathesis ? patients with second primary cancer within 5 years, exept adequately treated basal skin cancer or carcinoma in-situ of the cervix or bladder, or low/intermediate risk prostate cancer (Gleason score = 7) with normal PSA levels ? any condition that could jeopardize the safety of the patient and their compliance of the study ? breast-feeding patients ? substance abuse, medical, psychological or social conditions that may interfere with the participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: ? To determine the efficacy of Gemcitabine/nab-Paclitaxel in first-line therapy of patients with cholangiocarcinoma ineligible for Cisplatin-based therapy. Results of the first 10 evaluable patients will be compared to patient outcomes from the cancer registry of the West German Cancer Center (patients treated with Gemcitabine-combinations, patients treated with monotherapies). Primary endpoint will be overall response rate (ORR) (complete remission and partial remission) ;Secondary Objective: Secondary objectives: ? Disease control rate (DCR) (complete remission, partial remission and stable disease for at least 8 weeks) (estimated 80%)* ? Progression free survival (PFS) (estimated 8 months)* ? PFS rate at 6 months (estimated 60%)* ? Overall survival (OS) (estimated 12 months)* ? Serological response (decrease in CA19-9 levels) ? Toxicity/safety ? Quality of life (QoL) ? Translational: correlation of tumor response with SPARC expression in tumor and stroma; mutational status of key oncogenes ? Tumor samles will be stored für subsequent analyses, if study is positive *based on the combination cisplatin/gemcitabine (Valle et al., 2010) ;Primary end point(s): overall response rate (ORR) (complete remission and partial remission);Timepoint(s) of evaluation of this end point: at least 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Disease control rate (DCR) (complete remission, partial remission and stable disease for at least 8 weeks) (estimated 80%)* ? Progression free survival (PFS) (estimated 8 months)? PFS rate at 6 months (estimated 60%)* ? Overall survival (OS) (estimated 12 months)* ? Serological response (decrease in CA19-9 levels) ? Toxicity/safety ? Quality of life (QoL) ? Translational: correlation of tumor response with SPARC expression in tumor and stroma; mutational status of key oncogenes ;Timepoint(s) of evaluation of this end point: at least 8 weeks | — |
Countries
Germany
Contacts
Public ContactPI
University Hospital Essen
Outcome results
None listed