Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
About this trial
This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring advanced adult primary liver cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, adult primary cholangiocellular carcinoma
Eligibility Criteria
One of the following histologically or cytologically confirmed cancers not amenable to treatment with combined chemotherapy and radiotherapy: Biliary tract (intrahepatic, extrahepatic, or ampulla of Vater) carcinoma Gallbladder carcinoma Unresectable or metastatic disease No CNS metastases Prior brain metastases treated with surgery or radiosurgery allowed provided treatment was completed at least 4 weeks ago and there is no evidence of CNS progression No clinically significant pericardial or pleural effusion or ascites unless able to be drained before study entry Performance status - ECOG 0-2 At least 3 months Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 3 times upper limit of normal (ULN) AST no greater than 5 times ULN Creatinine no greater than 1.5 times ULN Creatinine clearance at least 45 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer Able to tolerate folic acid, corticosteroids, or cyanocobalamin supplements More than 4 weeks since prior biologic or immunologic therapy No prior biologic or immunologic therapy for metastatic disease No concurrent immunotherapy No concurrent colony-stimulating factors during course 1 No prior chemotherapy for metastatic disease No prior gemcitabine Prior chemoembolization allowed provided the following are true: At least 4 weeks since prior chemoembolization Evidence of new tumor growth since therapy At least 6 months since prior chemotherapy used as a radiosensitizer (in adjuvant setting or for locally advanced disease) No other concurrent chemotherapy Prior radiofrequency ablation allowed provided the following are true: At least 4 weeks since prior radiofrequency ablation Evidence of new tumor growth since therapy No prior radiotherapy to 25% or more of the bone marrow More than 4 weeks since prior radiotherapy No concurrent radiotherapy Prior embolization allowed provided the following are true: At least 4 weeks since prior embolization Evidence of new tumor growth since therapy No prior pemetrexed disodium No aspirin or nonsteroidal anti-inflammatory drugs for at least 2 days (5 days for long-acting agents [e.g., piroxicam]) before, during, and for at least 2 days after administration of pemetrexed disodium No concurrent cyclo-oxygenase-2 inhibitors
Sites / Locations
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Green Bay Oncology, Limited - Escanaba
- Dickinson County Healthcare System
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Rutherford Hospital
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
Arms of the Study
Arm 1
Experimental
pemetrexed + gemcitabine
Phase II: Patients receive pemetrexed disodium as in phase I and gemcitabine at the recommended phase II dose. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.