Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers

Stopped early · Phase 2

Conditions studied: Adult Primary Cholangiocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Localized Unresectable Adult Primary Liver Cancer, Periampullary Adenocarcinoma, Recurrent Adult Primary Liver Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer

In brief

This phase II trial is studying how well giving cediranib maleate together with combination chemotherapy works in treating patients with advanced biliary cancers. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cediranib maleate together with combination chemotherapy may kill more tumor cells.

Key facts

Study ID

NCT01229111

Run by

National Cancer Institute (NCI)

People needed

14

Starts

2010-10-01

Expected to finish

2014-03-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histopathological or cytopathological diagnosis of advanced biliary carcinoma (gallbladder cancer, cholangiocarcinoma, ampullary cancer) not amenable to conventional surgical approach are eligible
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan
• No patients with untreated brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
• Life expectancy of greater than 12 weeks
• White blood cell (WBC)/leukocytes ≥ 3,000/μL
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/μL
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 3 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 times institutional upper limit of normal
• Creatinine within normal institutional limits OR calculated creatinine clearance ≥ 60 mL/min
• No patients with proteinuria not meeting the criteria below; urine sample must be tested by urine protein:creatinine (UPC) ratio or by urinalysis method within 1 week of starting study treatment; depending upon the testing method used, the following criteria must be met:
• UPC ratio must be < 1.0; if UPC ratio is ≥ 1.0, a 24-hour urine specimen must be collected and must demonstrate < 1 g of protein
• Urinalysis must indicate 0-1+ protein; if urinalysis reading is ≥ 2+, a 24-hour urine specimen must be collected and must demonstrate < 1 g of protein
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use adequate contraception (hormonal or barrier method of birth control; abstinence) before and during study treatment
• Acceptable contraception includes abstinence, oral contraceptives, intra-uterine device (IUD), diaphragm, Norplant, approved hormone injections, condoms, or documentation of medical sterilization
• Patients with evidence of heart disease must be New York Heart Association (NYHA) Class I or II
• NYHA Class II patients controlled with treatment are considered at increased risk for compromised left ventricular ejection fraction (LVEF) and will undergo increased cardiac monitoring
• No patients with other active invasive cancers except nonmelanoma skin cancer or carcinoma in-situ of the cervix
• History of prior cancer is allowed as long as there has been no evidence of disease within the past 5 years
• No patients with mean corrected QT interval (QTc) > 480 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome
• No patients with uncontrolled hypertension defined as systolic blood pressure (BP) ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg, with or without anti-hypertensive medication or history of hypertensive crisis or hypertensive encephalopathy

Where it is running

• Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
• Ireland Cancer Center Landerbrook Health Center — Mayfield Heights, Ohio, United States
• Lake University Ireland Cancer Center — Mentor, Ohio, United States
• UHHS-Chagrin Highlands Medical Center — Orange, Ohio, United States
• UH-Seidman Cancer Center at Saint John Medical Center — Westlake, Ohio, United States

Full record on ClinicalTrials.gov

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