Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery

NCT02520141 | Completed Phase 2 Results

• 2 other identifiers: 2015-0393NCI-2015-01442
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholangiocarcinoma; Liver and Intrahepatic Bile Duct Carcinoma; Stage III Gallbladder Cancer AJCC v7; Stage III Intrahepatic Cholangiocarcinoma AJCC v7; Stage IIIA Gallbladder Cancer AJCC v7; Stage IIIB Gallbladder Cancer AJCC v7; Stage IV Gallbladder Cancer AJCC v7; Stage IVA Gallbladder Cancer AJCC v7; Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7; Stage IVB Gallbladder Cancer AJCC v7; Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7; Unresectable Gallbladder Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival of Ramucirumab in Advanced Biliary Cancers

  Progression free survival is measured using 95% confidence intervals. From the date of treatment start to the date of disease progression or to the date of death, whichever occurs first, or to the last follow-up date if patients are alive without disease progression, assessed up to at least 3 months post-treatment

  Up to 6 years

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to 6 years

• Overall Response Rate (RR)

  Up to 6 years

• Percentage of Disease Control Rate

  Up to 6 years

Study Arms (1)

Treatment (ramucirumab)

EXPERIMENTAL

Patients receive ramucirumab IV over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Biological: Ramucirumab

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ramucirumab)

Ramucirumab BIOLOGICAL

Given IV

Also known as: anti-VEGFR-2 fully human monoclonal antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806, Monoclonal Antibody HGS-ETR2

Treatment (ramucirumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+ (\>=100-300 mg/dl), a 24-hour urine collection for protein must demonstrate \< 1000 mg of protein in 24 hours to allow participation in this protocol)

You may not qualify if:

• The patient has experienced any grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to enrollment
• Prior therapy with any agent targeting the vascular endothelial growth factor receptor (VEGFR) pathway to include bevacizumab, pazopanib, and other anti-angiogenesis inhibitors
• The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism, including portal venous thrombosis (venous port or catheter thrombosis, incidental pulmonary embolism diagnosed on imaging studies or superficial venous thrombosis are not considered significant) during the 3 months prior to randomization
• The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment
• The patient has uncontrolled or poorly-controlled hypertension (\> 160 mmHg systolic or \> 100 mmHg diastolic for \> 4 weeks) despite standard medical management
• The patient has a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
• The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
• The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (\[NSAIDs\], including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
• The patient has elective or planned major surgery to be performed during the course of the clinical trial
• The patient is pregnant or breast-feeding

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Cholangiocarcinoma; Carcinoma, Hepatocellular; Gallbladder Neoplasms

Interventions

Ramucirumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Milind Javle
• Organization: M D Anderson Cancer Center

mjavle@mdanderson.org

(713) 792-5434

Study Officials

• Rachna T Shroff

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 11, 2015
• Study Start: December 29, 2015
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-05

Locations

US (1)