Ramucirumab for Advanced Pre-treated Biliary Cancers

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 50
• Participant gender: Both

Summary

The goal of this clinical research study is to learn if ramucirumab can help to control biliary cancer. The safety of this drug will also be studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Eli Lilly and Company
• Treatments: Ramucirumab
• Last Updated: 2016-06-30

Criteria

Inclusion Criteria:

1. Patient must have cholangiocarcinoma, gallbladder cancer or adenocarcinoma on liver biopsy with clinical features consistent with biliary primary/ cholangiocarcinoma.

2. Metastatic or unresectable disease documented on diagnostic imaging studies.

3. Must have received =/< 2 prior regimens, at least one regimen containing gemcitabine for advanced or metastatic disease.

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

5. The patient has adequate hepatic function as defined by a total bilirubin =/<1.5 mg/dL (25.65 μmol/L), and 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).

6. The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) =/>1000/µL, hemoglobin =/>9 g/dL (5.58 mmol/L), and platelets =/>100,000/µL.

7. The patient does not have: a. Cirrhosis at a level of Child-Pugh B (or worse) or; b. 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.

8. The patient has adequate renal function as defined by a 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).

9. The patient's urinary protein is =/<1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is =/>2+, a 24-hour urine collection for protein must demonstrate <1000 mg of protein in 24 hours to allow participation in this protocol).

10. The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) =/<1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x ULN.). Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin. If receiving warfarin, the patient must have an INR =/<3.0 and no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices).

11. Because the teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods).

12. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.

13. Patients must sign an Informed Consent and Authorization indicating that they are aware of the investigational nature of this study and the known risks involved.

14. Patient is =/> 18 years of age on the day of consenting to the study.

Exclusion Criteria:

1. The patient has experienced any Grade 3-4 GI bleeding within 3 months prior to enrollment.

2. Prior therapy with any agent targeting the VEGFR pathway to include bevacizumab, pazopanib, and other anti-angiogenesis inhibitors.

3. 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 or superficial venous thrombosis are not considered "significant") during the 3 months prior to randomization.

4. 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.

5. The patient has uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management.

6. The patient has a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.

7. The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment.

8. 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.

9. The patient has elective or planned major surgery to be performed during the course of the clinical trial.

10. The patient is pregnant or breast-feeding.