Cholangiocarcinoma Cholangiocarcinoma S-
Conditions
Interventions
1 (40-
60 mg bid) and LV (15 mg bid) were orally administered for 1 week,
followed by 1 week rest period for 6 months,
until disease progression,
unacceptable toxicity,
patient or physician decision to discontinue,
or death
Dosages and schedule
S-
1 and leucovorin po twice daily for 1 week,
every 2 weeks:
S-
1 (40,
50 and 60 mg for BSA <1.25,
1.25-
1.5 and 1.5 m2,
po twice daily)
Leucovorin (15 mg po twice daily)
Experimental Drug
S1+leucovorin
Sponsors
Chulabhorn Hospital
Faculty of medicine,
Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to 0 Years
Inclusion criteria
Inclusion criteria: • Ability and willingness to provide written informed consent and to comply with the study protocol • Male or female, 18 years of age or older • ECOG performance status of 0 or 1 • Life expectancy > 3 months • Histologically confirmed adenocarcinoma of the bile duct with inoperable, metastatic disease, not amenable to curative therapy • Radiographic evidence of disease; measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Patients with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial. • For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use an adequate method of contraception (a method with a failure rate of < 1% per year, such as hormonal implants, combined oral contraceptives, or a vasectomized partner) during the treatment period and for at least 6 months after the last dose of S-1 and leucovorin • For men: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of S-1 and leucovorin
Exclusion criteria
Exclusion criteria: • Previous chemotherapy for locally advanced cholangiocarcinoma Patients may have received either neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to enrollment. • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, localized prostate cancer that has been treated surgically with curative intent and presumed cured, or other malignancies with an expected curative outcome • Granulocyte count 1.5 x the upper limit of normal (ULN), except for patients receiving anticoagulation therapy • AST (SGOT), ALT (SGPT), alkaline phosphatase (ALP) ≥ 2.5 × ULN (≥ 5 × ULN with liver metastases) • Total bilirubin ≥ 1.5 × ULN (except in patients diagnosed with Gilbert’s disease) • Serum calcium > ULN (corrected for low serum albumin concentrations) Corrected calcium (mg/dL) = serum Ca2+ + [(4.0–measured serum albumin) x 0.8] Corrected calcium (mmol/L) = serum Ca2+ + 0.02 × (40–serum albumin) • Serum creatinine > 1.5 × ULN or calculated creatinine clearance 200 mg/dL • Pregnancy or lactation • Receipt of an investigational drug within 28 days prior to initiation of study drug • Clinically significant gastrointestinal abnormalities, apart from gastric cancer, including uncontrolled inflammatory gastrointestinal diseases (Crohn’s disease, ulcerative colitis, etc.) • Significant history of cardiac disease (i.e., unstable angina, congestive heart failure, as defined by the New York Heart Association [NYHA] as Class II, III, or IV) within 6 months prior to Day 1 of Cycle 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication • Significant vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1 • Serious (Grade ≥ 3) active infection at the time of enrollment, or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment • Known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), or known HIV-seropositivity. • Radiotherapy within 4 weeks before start of study treatment (2-week interval allowed following palliative radiotherapy given to peripheral bone metastatic site and patient has recovered from all acute toxicities) • Major surgery within 4 weeks before start of study treatment, without complete recovery • Any condition (e.g., psychological, geographical, etc.) that does not permit compliance with study and follow-up procedures • Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase [DPD] deficiency) or patients with known DPD deficiency • Known sensitivity or contraindication to any component of study treatment • Active (significant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate, progression free survival every 12 week CT/MRI scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety every 2 week Questionnaire,overall survival, duration of response every 12 week CT/MRI | — |
Countries
Thailand
Contacts
Public ContactSuebpong Tanasanvimon
Faculty of medicine, Chulalongkorn University
Outcome results
None listed