Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors (ABC-02)
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
About this trial
This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring cholangiocarcinoma of the extrahepatic bile duct, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, cholangiocarcinoma of the gallbladder, recurrent gallbladder cancer, unresectable gallbladder cancer, metastatic extrahepatic bile duct cancer, metastatic gallbladder cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma Intra- or extra-hepatic disease allowed Unresectable locally advanced, recurrent, or metastatic disease No brain metastases PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL (transfusion allowed) WBC ≥ 3,000/mm^3 Hepatic AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin ≤ 1.5 times ULN Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present) Adequate biliary drainage No unresolved biliary tract obstruction Renal Creatinine < 1.5 times ULN Urea < 1.5 times ULN Glomerular filtration rate (GFR) ≥ 45 mL/min If GFR < 60 mL/min, isotope EDTA confirmation of adequate renal function is required Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No active, uncontrolled infection No other severe or uncontrolled systemic disease No other malignancy within the past 5 years except nonmetastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection No psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Chemotherapy At least 6 months since prior adjuvant chemotherapy No prior gemcitabine hydrochloride No prior cisplatin No prior systemic chemotherapy for locally advanced or metastatic disease except low-dose radiosensitizing chemotherapy in conjunction with radiotherapy Radiotherapy Prior radiotherapy for localized disease allowed provided there is clear evidence of disease progression afterwards Surgery Prior curative surgery allowed provided there is evidence of nonresectable disease relapse requiring systemic chemotherapy Other Recovered from all prior therapies Prior photodynamic therapy (PDT) allowed provided it was given for localized disease only (with no evidence of metastatic disease) and resulted in subsequent disease progression after completion of therapy OR to relieve biliary obstruction in the presence of metastatic disease PDT must have been completed ≥ 4 weeks ago At least 4 weeks since prior investigational agents No other concurrent, curative anticancer therapy
Sites / Locations
- Basingstoke and North Hampshire NHS Foundation Trust
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
- Addenbrooke's Hospital
- Cumberland Infirmary
- Gloucestershire Oncology Centre at Cheltenham General Hospital
- Derbyshire Royal Infirmary
- Princess Alexandra Hospital
- Gloucestershire Royal Hospital
- Princess Royal Hospital at Hull and East Yorkshire NHS Trust
- Leeds Cancer Centre at St. James's University Hospital
- Helen Rollason Cancer Care Centre at North Middlesex Hospital
- Royal Marsden - London
- Hammersmith Hospital
- UCL Cancer Institute
- University College of London Hospitals
- Maidstone Hospital
- Clatterbridge Centre for Oncology
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Nottingham City Hospital
- Portsmouth Oncology Centre at Saint Mary's Hospital
- Cancer Research Centre at Weston Park Hospital
- Belfast City Hospital Trust Incorporating Belvoir Park Hospital
- Aberdeen Royal Infirmary
- Velindre Cancer Center at Velindre Hospital
- Glan Clwyd Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
A - Gemcitabine
B - Gemcitabine and Cisplatin
Gemcitabine alone
Gemcitabine and Cisplatin