Phase 2
N=26
Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00335829 ↗Enrolled (actual)
26
Serious AEs
23.1%
Results posted
Aug 2017
Primary outcome: Primary: Median Progression-free Survival
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Biological); chemotherapy (Drug); embolization therapy (Drug); hepatic artery infusion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression-free Survival |
— | — |
| PRIMARY Time to Tumor Progression (TTP) of Targeted Lesions |
NA | — |
| SECONDARY TTP of Nontargeted Lesions Within the Liver |
9.1 | — |
| SECONDARY Overall TTP |
7.2 | — |
| SECONDARY TTP Rate at 6 Months and 1 Year |
65; 23 | — |
| SECONDARY Overall Survival (OS) |
10.8; 23.6 | — |
| SECONDARY Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST) |
0; 8; 15; 0; 8; 23 | — |
| SECONDARY Response Rate - Based on Tumor Enhancement |
4; 10; 9; 0; 14; 23 | — |
| SECONDARY Safety and Treatment Toxicity - Cycle 1 Pre-TACE |
3; 2; 1; 1; 1; 2 | — |
| SECONDARY Safety and Treatment Toxicity - Cycle 1 Post-TACE |
10; 7; 8; 3; 1; 10 | — |
| SECONDARY Safety and Treatment Toxicity - Cycles 2 and 3 |
7; 12; 1; 2; 5; 11 | — |
Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together with chemoembolization may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed* hepatocellular carcinoma
- Unresectable disease
- Child's class A or B with liver-predominant and asymptomatic extrahepatic disease NOTE: *A highly suspicious liver mass on CT scan or MRI in the presence of alpha fetoprotein > 200 mg/dL may be used as alternative diagnostic criterion
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 50,000/mm³
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 50 mL/min
- No significant traumatic injury within the past 28 days
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No serious, nonhealing wound, ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
- No major surgery or open biopsy within the past 28 days
- No minor surgery (e.g., fine-needle aspirations or core biopsies) within the past 7 days
- No chemotherapy within the past 4 weeks
- No radiotherapy within the past 21 days
- No concurrent major surgery
- No other concurrent chemotherapy
- No other concurrent investigational drugs
Data sourced from ClinicalTrials.gov (NCT00335829). 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.