Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers … (NCT02520141) | Clinical Trial Compass
CompletedPhase 2
Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery
United States61 participantsStarted 2015-12-29
Plain-language summary
This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must have cholangiocarcinoma, gallbladder cancer or adenocarcinoma on liver biopsy with clinical features consistent with biliary primary/cholangiocarcinoma
* Metastatic or unresectable disease documented on diagnostic imaging studies
* Must have received at least one regimen containing gemcitabine chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Total bilirubin =\< 1.5 mg/dL (25.65 mol/L)
* Aspartate transaminase (AST) and alanine transaminase (ALT) =\< 3.0 times the upper limit of normal (\[ULN\]; or 5.0 times the ULN in the setting of liver metastases)
* Absolute neutrophil count (ANC) \>= 1000/uL
* Hemoglobin \>= 9 g/dL (5.58 mmol/L)
* Platelets \>= 100,000/uL
* The patient does not have:
* Cirrhosis at a level of Child-Pugh B (or worse) or
* Cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
* Serum creatinine =\< 1.5 times the ULN or
* Creatinine clearance (measured via 24-hour urine collection) \>= 40 mL/minute (that is, if serum creatinine is \> 1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed
* The patient's urinary protein is =\< 1 positive (+) (=\< 30-100 mg/dl) on dipstick or routine urinalysis (urinary analysis \[UA\]; if urine dipstick or routine analysis is \>= 2+ (\>=…
What they're measuring
1
Progression Free Survival of Ramucirumab in Advanced Biliary Cancers