Phase 2
N=30
Chemoembolization and Bevacizumab in Treating Patients With Liver Cancer That Cannot Be Removed With Surgery
Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00049322 ↗Enrolled (actual)
30
Serious AEs
20.7%
Results posted
Mar 2016
Primary outcome: Primary: Neovessel Formation as Measured by Angiogram at 14 Weeks — 2; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jonsson Comprehensive Cancer Center
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neovessel Formation as Measured by Angiogram at 14 Weeks |
2; 3 | — |
| SECONDARY Progression Free Survival |
.79; .19 | — |
| SECONDARY Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment |
3; 6; 5; 4; 8; 1 | — |
| SECONDARY Assess Pharmakokinetics of Bevacizumab in Liver Disease |
203; 237; 35.4; 297; 74.3; 280 | — |
| SECONDARY Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab |
.053; .167; .161; .048; .039; .063 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, cisplatin, and mitomycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Monoclonal antibodies, such as bevacizumab, can kill any tumor cells that are left after chemoembolization by blocking their ability to grow and spread.
PURPOSE: This randomized phase II trial is studying to see if chemoembolization followed by bevacizumab works better than chemoembolization alone in treating patients who have liver cancer that cannot be removed with surgery.
Eligibility Criteria
Inclusion Criteria
- Age > 18 year old
- Histologically or cytologically documented HCC
- Patients must have bi-dimensional measurable disease by CT or MRI scan that does not exceed 50% of the liver parenchyma
- Patients must be considered clinical candidates for chemoembolization, with at least one lesion > 3cm and no lesion > 15cm in its longest diameter
- Patients awaiting cadaveric orthotopic liver transplantation are eligible if they meet all other criteria. These patients must have a model for end-stage liver disease priority score 2.5mg/dl
- Thrombosis of the main portal vein
- Absolute contraindications to doxorubicin, mitomycin-C, cisplatin, iodinated contrast material, Avitene or dexamethasone treatment
- Other active malignancies during the past year (except for non-melanoma skin cancer or in situ carcinomas)
- ECOG PS> 2 or life expectancy 325mg/day) or nonsteroidal anti-inflammatory medications
- Positive pregnancy test or lactation
- Proteinuria at baseline or clinically significant impairment of renal function. Subjects unexpectedly discovered to have > 1+ proteinuria at baseline should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate 1.5
- Total bilirubin of > 2.5mg/dL
- AST or ALT > 5 times upper limit of normal
- Serum creatinine of > 2.0 mg/dL or creatinine clearance < 45 mL/min
- Hemoglobin of < 8.5 gm/dL
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
Data sourced from ClinicalTrials.gov (NCT00049322). 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.