A phase III clinical study to compare paclitaxel (Genexol®-PM) in combination with standard therapy (gemcitabine/cisplatin) and standard therapy alone (gemcitabine/cisplatin) in patients with advanced biliary tract

Not Applicable

Terminated

• Conditions: Neoplasms

• Registration Number: KCT0003726
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-07
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Patients between 19 and 79 years old
- Cytologically or histologically confirmed adenocarcinoma of biliary tract (gallbladder, intrahepatic, and extrahepatic bile ducts) with or without measurable lesion according to RECIST version 1.1
- Locally advanced unresectable, initially metastatic, and recurred disease
- At least one or more evaluable lesions without prior radiotherapy
- Patients with or without prior external or internal biliary drainage procedure (e.g., percutaneous transhepatic biliary drainage, endoscopic retrograde biliary drainage)
- No previous chemotherapy except adjuvant chemotherapy with fluoropyrimidine-based regimen which completed 6 months or before
- Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 2
- Adequate bone marrow function as defined by platelets = 100 x 109/L and neutrophils = 1.5 x 109/L
- Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN)
- Adequate hepatic function with serum total bilirubin < 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 x ULN
- No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent > 5 years previously without evidence of relapse
- Written informed consent to the study

Exclusion Criteria

- Age=80 years
- Histologically diagnosed adenosquamous carcinoma
- AoV cancer
- History of severe neurologic disorder or psychiatric disorder
- Radiation therapy taken within 4 weeks
- Gastrointestinal obstruction
- Severe gastrointestinal bleeding
- Medical history with coronary angioplasty, stent insertion, bypass within 6months
- Myocardial infarction or other clinically significant heart disease within 6 months of initiation of the study treatment
- High risk of cardiovascular conditions (including patients with recent coronary stent implantations, with myocardial infarction within 6 months, and with arrhythmia with unstable symptoms)
- Past or present history of uncontrolled HIV, uncontrolled hepatitis B or C (in case of chronic hepatitis B or HBV carrier, HBV DNA level should be lower than 200IU/mL)
- Severe and/or uncontrolled medical conditions which may interfere with participation in the study, including significant active or uncontrolled infection (bacterial, viral, and fungal infection)
- Allergy or hypersensitivity reaction to paclitaxel, gemcitabine, cisplatin, or Cremophor EL; patients with symptoms in Contraindications and Precautions
- Patients with genetic problems including galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption
- interstitial pneumonitis or pulmonary fibrosis clearly visible on the x-ray with clinical symptoms
- Hearing impairment
- Cisplatin-induced neuropathy
- Other serious diseases or medical conditions
- Pregnant or lactating women or women of childbearing potential who do not consider appropriate contraceptives

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (be evaluated by the site investigators);Objective response rate to RECIST(Response evaluation criteria in solid tumors) guidelines;Safety profile;Progression-free survival (be evaluated by the independent reviewer)