A PHASE II, TWO CENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY AND SAFETY OF S-1 PLUS LEUCOVORIN IN PATIENTS WITH ADVANCED CHOLANGIOCARCINOMA
- Conditions
- CholangiocarcinomaSǃLeucovorin
- Registration Number
- TCTR20160313001
- Lead Sponsor
- Chulabhorn Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
• 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
• 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 < 1500/mm3, platelet count < 100,000/mm3, and hemoglobin < 9.0 g/dL
within 7 days prior to enrollment
• Partial thromboplastin time (PTT), international normalized ratio (INR), or prothrombin time
(PT) > 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+ + [(4.0â€measured serum albumin) x 0.8]
Corrected calcium (mmol/L) = serum Ca2+ + 0.02 × (40â€serum albumin)
• Serum creatinine > 1.5 × ULN or calculated creatinine clearance < 60 mL/min
• Uncontrolled diabetes as evidenced by fasting serum glucose level > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate, progression free survival every 12 week CT/MRI scan
- Secondary Outcome Measures
Name Time Method Safety every 2 week Questionnaire,overall survival, duration of response every 12 week CT/MRI