Locally advanced or metastatic adenocarcinoma of the biliary tract (intra or extra-hepatic biliary ducts, gallbladder, Ampulla of Vater). MedDRA version: 14.1 Level: LLT Classification code 10025734 Term: Malignant neoplasm of biliary tract, part unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutic
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated IRB/IEC-approved Informed Consent. 2. Diagnosis of locally advanced or metastatic adenocarcinoma of the biliary tract (Ampulla of Vater, gallbladder, intra or extra-hepatic biliary ducts). 3. Disease progressing after first-line chemotherapy with gemcitabine and platinum analogs (only one prior systemic therapy allowed). 4. Age 18-75 years and Karnofsky Performance Status > 50%. 5. Adequate bone marrow, liver and kidney function. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasm without evidence of disease at least from 5 years. 2. Known brain metastases. 3. Clinically significant cardiovascular disease </= 1 year prior to dosing. 4. Clinically significant disease including Cerebral Vascular Accident. 5. History of interstitial lung disease or evidence of interstitial lung disease on baseline chest CT scan. 6. Known positive tests for human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C. 7. Subject who is pregnant or breast feeding. 8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the therapeutic activity of capecitabine alone or in combination with mitomycin C in terms of progression-free survival rate at 6 months from treatment start in patients with advanced/metastatic biliary adenocarcinoma in progression after gemcitabine and platinum compounds.;Secondary Objective: 1. Assessment of additional measures of tumor control to further characterize the efficacy profile of capecitabine alone or in combination with mitomycin C. 2. Evaluation of the safety profile of capecitabine alone or in combination with mitomycin C. 3. Study of the prognostic / predictive role of proteic markers.;Primary end point(s): Progression-free survival rate at 6 months from treatment start (PFS-6 rate).;Timepoint(s) of evaluation of this end point: At 6 months from treatment start. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Progression-free survival. 2. Overall Survival (OS). 3. Objective Response Rate (CR+PR), Disease Control Rate, Duration of Response. 4. Overall safety profile. 5. Basal expression of thymidine synthase and thymidine phosphorylase in tumor.;Timepoint(s) of evaluation of this end point: 1. Time of disease progression. 2. Date of death. 3. All treatment period. 4. All cycles, from enrollment to 42 days after last treatment. 5. At the end of the study. | — |
Countries
Italy
Contacts
Public ContactOncologia Medica
Fondazione Centro San Raffaele del Monte Tabor
Outcome results
None listed