Clinical Trials Logo
  1. Home
  2. Efficacy
  3. NCT00504192

A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer

Efficacy Clinical Trial

Official title:
A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma

Clinical Trial Summary

The role of systemic chemotherapy in advanced biliary tract cancer (BTC) is known to be very limited although various single-agent or combination therapies had been tested. However, there is a possibility that palliative chemotherapy induce prolong survival and improve quality of life in advanced BTC based on several studies. A GERCOR study showed the promising result of gemcitabine in combination with oxaliplatin as first line chemotherapy in advanced BTC. Therefore, this phase II trial was planned to investigate efficacy and toxicity of combination chemotherapy with gemcitabine and dose adjusted oxaliplatin in patients with inoperable BTC in Korea.

Clinical Trial Description

Treatment scheme

:Gemcitabine 1000 mg/m2/d IV D1 as a 10mg/m2/min Oxaliplatin 85 mg/m2/d IV D2 as a 2 hours infusion

Each cycle is repeated every 2 weeks.

Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity. Subjects will be treated for at least 4 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00504192
Study type Interventional
Source Soonchunhyang University Hospital
Contact
Status Completed
Phase Phase 2
Start date September 2006
Completion date March 2009
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT00944268 - Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety Phase 3
Recruiting NCT05580159 - New Generation mRNA Booster Vaccine Against Emerging VOCs Phase 3
Completed NCT05427305 - TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer Phase 3
Active, not recruiting NCT05686161 - mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs Phase 3
Recruiting NCT06284746 - Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer Phase 2
Completed NCT04260113 - Apatinib for Inoperable Advanced Chondrosarcoma N/A
Recruiting NCT06120712 - A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of Advanced Melanoma (MIZAR-002) Phase 1/Phase 2
Active, not recruiting NCT04002440 - Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight N/A
Recruiting NCT02693587 - Misodel or Angusta for Induction of Labour? N/A
Completed NCT01194453 - Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer Phase 2
Recruiting NCT05276557 - PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study Phase 3
Recruiting NCT06205758 - Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency
Recruiting NCT06122454 - A Phase Ic/IIb Study to Evaluate the Efficacy，Safety and Pharmacokinetics of HST in Patients With CHB Phase 1/Phase 2
Recruiting NCT05913271 - Study on the Correlation Between NAT2(N-acetyltransferase2) Gene Polymorphism and CrCl(Creatine Clreance) and the Efficacy and Safety of Levosimendan in Patients With Severe Heart Failure
Recruiting NCT05999656 - Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot N/A
Recruiting NCT05731258 - Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Recruiting NCT03908138 - RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma Phase 4
Completed NCT05648799 - Pharmacokinetics, Safety and Efficacy Study of GP30341 (GEROPHARM, Russia) in Healthy Volunteers and Outpatients With COVID-19 N/A
Recruiting NCT03377933 - The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection N/A
Recruiting NCT04069780 - Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema N/A