Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors
- Conditions
- Extrahepatic Bile Duct CancerGallbladder Cancer
- Interventions
- Registration Number
- NCT00262769
- Lead Sponsor
- University College, London
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors.
PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.
- Detailed Description
OBJECTIVES:
Primary
* Compare the overall survival of patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine hydrochloride with vs without cisplatin.
Secondary
* Compare the progression-free survival of patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary site of disease (gallbladder vs bile ducts vs ampulla), prior therapy (photodynamic therapy \[PDT\] vs non-PDT therapy vs none), ECOG performance status (0 vs 1 vs 2), and disease status (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1Ā½ hours on days 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 12 weeks, and after finishing treatment.
After completion of study treatment, patients are followed periodically for at least 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 324
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A - Gemcitabine gemcitabine hydrochloride Gemcitabine alone B - Gemcitabine and Cisplatin cisplatin Gemcitabine and Cisplatin B - Gemcitabine and Cisplatin gemcitabine hydrochloride Gemcitabine and Cisplatin
- Primary Outcome Measures
Name Time Method Overall Survival From date of randomisation till date of death or last date of follow-up (up to 5 years) From date of randomisation till date of death or last date of follow-up (up to 5 years)
- Secondary Outcome Measures
Name Time Method Progression-free survival From date of randomisation till date of death or last date of follow-up (up to 5 years) From date of randomisation till date of death or last date of follow-up (up to 5 years)
Quality of life Before and 12 weeks after completion of treatment Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically
Toxicity During treatment and follow-up Toxicity as measured by NCI CTC periodically. The proportion of patients who experience a toxicity of grade 3 or 4 will be compared between the two arms of the trial.
Trial Locations
- Locations (25)
Helen Rollason Cancer Care Centre at North Middlesex Hospital
š¬š§London, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
š¬š§Hull, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
š¬š§Leeds, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
š¬š§Northwood, England, United Kingdom
Derbyshire Royal Infirmary
š¬š§Derby, England, United Kingdom
Cumberland Infirmary
š¬š§Carlisle, England, United Kingdom
Glan Clwyd Hospital
š¬š§Rhyl, Denbighshire, Wales, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
š¬š§Basingstoke, England, United Kingdom
Nottingham City Hospital
š¬š§Nottingham, England, United Kingdom
UCL Cancer Institute
š¬š§London, England, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
š¬š§Birmingham, England, United Kingdom
Addenbrooke's Hospital
š¬š§Cambridge, England, United Kingdom
Princess Alexandra Hospital
š¬š§Essex, England, United Kingdom
Maidstone Hospital
š¬š§Maidstone, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
š¬š§Portsmouth Hants, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
š¬š§Cardiff, Wales, United Kingdom
Clatterbridge Centre for Oncology
š¬š§Merseyside, England, United Kingdom
Royal Marsden - London
š¬š§London, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
š¬š§Cheltenham, England, United Kingdom
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
š¬š§Belfast, Northern Ireland, United Kingdom
University College of London Hospitals
š¬š§London, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
š¬š§Sheffield, England, United Kingdom
Aberdeen Royal Infirmary
š¬š§Aberdeen, Scotland, United Kingdom
Gloucestershire Royal Hospital
š¬š§Gloucester, England, United Kingdom
Hammersmith Hospital
š¬š§London, England, United Kingdom