ab-Paclitaxel (Abraxane®) and Gemcitabine as first line therapy in patients with cholangiocarcinoma - The NACHO trial

Phase 1

• Conditions: unresecable, metastatic or recurrent cholangiocarcinoma (intrahepatic cholangiocellular carcinoma, bile duct cancer, gall bladder carcinoma); MedDRA version: 18.1Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004981-52-DE
• Lead Sponsor: niversity Hospital Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-17
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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 < 60 ml/min), impaired hearing, increased risk or history for thromboembolic events, intolerance of extensive hydration, left ventricular ejection fraction (LVEF) < 45%
?adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening
?absolute neutrophil count (ANC) = 1500/µl
?platelet count = 100,000/µl
?total bilirubin < 3 x ULN and sufficient biliary drainage
?ALT and AST < 3 x ULN, < 5 x ULN if liver metastasis present
?PT-INR/PTT < 1.5 x ULN, patients therapeutically anticoagulated with NMH, heparin or NOACs (dabigatran, rivaroxaban, abixaban) are allowed to participate, patients anticoagulated with phenoprocoumon or warfarin should be switched to NMH, heparin or NOACs
?creatinine clearance = 30ml/min and serum creatinine = 2.5 x ULN
?confirmed menopause, negative pregnancy test within 7 days of the start of treatment and willingness to use highly effective methods of contraception
?willingness and able to comply with the protocol for the duration of the study

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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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

Study & Design

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