Phase 2
N=61
Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery
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
Bottom Line
View on ClinicalTrials.gov: NCT02520141 ↗Enrolled (actual)
61
Serious AEs
1.7%
Results posted
Jun 2023
Primary outcome: Primary: Progression Free Survival of Ramucirumab in Advanced Biliary Cancers — 3.2 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Ramucirumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival of Ramucirumab in Advanced Biliary Cancers |
3.2 | — |
| SECONDARY Overall Survival (OS) |
9.5 | — |
| SECONDARY Overall Response Rate (RR) |
1 | — |
| SECONDARY Percentage of Disease Control Rate |
45 | — |
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.
Eligibility Criteria
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 = = 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 = = 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 = = 2+ (>=100-300 mg/dl), a 24-hour urine collection for protein must demonstrate 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
Data sourced from ClinicalTrials.gov (NCT02520141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.