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.
OBJECTIVES: Primary * Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy. Secondary * Characterize the safety and toxicity of this regimen in these patients. * Determine the response rate in patients treated with this regimen. OUTLINE: Patients receive bevacizumab once in weeks 1, 3, and 5. Beginning in week 3, patients also receive transarterial chemoembolization (TACE) therapy. Treatment repeats approximately every 8 weeks for up to 3 courses. Patients achieving \< 100% necrosis by MRI after the first course receive 2 additional courses of bevacizumab and TACE. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Median Progression-free Survival
This outcome was not assessed. Instead, the primary outcome of time to tumor progression (TTP) of the targeted lesions and secondary outcomes of TTP of nontargeted lesions and overall TTP were assessed and reported.
Time frame: Time through study completion, an average of 1 year
Time to Tumor Progression (TTP) of Targeted Lesions
Time to tumor progression was estimated via Kaplan-Meier methodology using the 23 patients who underwent treatment.
Time frame: 6 months and 1 year
TTP of Nontargeted Lesions Within the Liver
TTP of nontargeted lesions assessed via Kaplan-Meier methodology.
Time frame: 1 year
Overall TTP
Overall TTP assessed via Kaplan-Meier methodology.
Time frame: 1 year
TTP Rate at 6 Months and 1 Year
Overall TTP assessed via Kaplan-Meier methodology at 6 months and 1 year
Time frame: 6 months and 1 year
Overall Survival (OS)
OS assessed via Kaplan-Meier methodology both from initiation of therapy and from the date of diagnosis until death.
Time frame: 1 year
Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 3 weeks after TACE, and 4 weeks after completion of final cycle. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Time frame: 6 months
Response Rate - Based on Tumor Enhancement
Efficacy as assessed by radiographic tumor response utilizing the following tumor enhancement criteria: Complete Response (CR): 100% tumor necrosis of the target lesion(s) upon completion of any of the 3 cycles of TACE therapy Partial Response (PR): Greater than 50% tumor necrosis of target lesion(s) Progressive Disease (PD): Reappearance or increased tumor enhancement greater than 25% in target lesion(s) Stable Disease (SD): Cases that do not meet CR or PR and did not demonstrate evidence of tumor progression.
Time frame: 6 months
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for all patients (n=26) who received bevacizumab prior to TACE therapy.
Time frame: Cycle 1 pre-TACE - 2 weeks
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for 25 who completed the first cycle of TACE and bevacizumab therapy
Time frame: Cycle 1 post-TACE - 5 weeks
Safety and Treatment Toxicity - Cycles 2 and 3
Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for patients (n=14) who completed 2 or 3 cycles of TACE and bevacizumab therapy
Time frame: 6 months
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