Pemetrexed in combination with erlotinib as a salvage treatment in patients with metastatic biliary tract cancer (BTC) who failed gemcitabine

Not Applicable

Active, not recruiting

• Conditions: Neoplasms

• Registration Number: KCT0005787
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

? Provide complete subject consent before any test designation procedure
? Adults over 19 years old
? Progressive metastatic biliary tract cancer that cannot be operated after failing treatment with gemcitabine.
-Those who only received primary chemotherapy
-Intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer? Patients must have the will and ability to comply with the clinical trial protocol during the trial period, including treatment, scheduled visits, and examinations.
? ECOG performance capability status 0~2.
? There must be a measurable lesion (RECIST 1.1)
? The patient's life expectancy should be at least 3 months from the proposed first administration date.
? Patients must have acceptable bone marrow, liver and kidney function test results measured within 28 days prior to administration of the test treatment as specified below:
A. Hemoglobin = 9.0 g/L (transfusion allowed)
B. Absolute neutrophil count (ANC) = 1.5 x 109/L
C. White blood cells (WBC)> 3 x 109/L
D. Platelet count = 100 x 109/L (transfusion allowed)
E. Total bilirubin = 1.5 x laboratory's upper limit of normal (ULN) (Glibert's disease is not included)
F. AST(SGOT)/ALT(SGPT) = 2.5 x Upper normal limit of laboratory. However, except for the presence of liver metastasis (must be = 5x ULN)
G. Serum creatinine = 1.5 x ULN of laboratory
? Urine or serum pregnancy test negative within 28 days of test treatment, confirmed before treatment on the first day (for women of childbearing potential)
? When the disease progresses, tissue biopsy can be performed if possible.
? Stored tissue or fresh tissue biopsy must be possible before starting treatment.

Exclusion Criteria

? Patients with poor general condition (patients with ECOG PS of 3 or higher).
? Patients with second primary cancer, Exception: Non-melanoma skin cancer that has been properly treated, cured cervical intraepithelial cancer, or other solid tumors cured within 5 years without evidence of disease.
? Patients in the acute stage of infection.
? Treatment with investigational drugs for the most recent 14 days (or a longer period depending on the prescribed characteristics of the product used) before registration.
? Patients who received systemic chemotherapy or radiation therapy (except for palliative purposes) within 3 weeks (or longer period depending on the prescribed characteristics of the formulation used) after the last administration before the trial treatment.
? Excluding hair loss, all toxicities in progress caused by previous cancer therapy (> CTCAE Grade 1).
? If the QTc measurable by ECG is> 480msec at rest at 2 or more times within 24 hours, or if there is a family history of QT prolonged syndrome.
? Patients with the following heart problems: uncontrolled high blood pressure (BP = 150/95mmHg despite medical treatment), left ventricular ejection coefficient <55% measured by echocardiography, an atrium with ventricular rate> 100 bpm on ECG at rest Fibrillation, symptomatic heart failure (grades NYHA II-IV), previous or present cardiomyopathy, severe valvular heart disease, uncontrolled angina (degrees II-IV of the Canadian Cardiovascular Society, despite medical treatment), 6 months prior to initiation of treatment Within acute coronary syndrome.
? There is evidence of severe or uncontrolled systemic disease, active infection, active bleeding constitution, or kidney transplant, including in patients known as hepatitis B, C, or human immunodeficiency virus (HIV).
? History of allergy or hypersensitivity to Pemetrexed, Erlotinib
? Pregnancy or breastfeeding
? Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose galactose absorption disorder

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate, progression-free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival, overall response rate, safety and toxic response profile