Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00335829|
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Biological: bevacizumab Drug: chemotherapy Drug: embolization therapy Procedure: hepatic artery infusion||Phase 2|
- Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy.
- 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 (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
|Experimental: single arm, received bevacizumab and TACE||
Drug: embolization therapy
Procedure: hepatic artery infusion
- Median Progression-free Survival [ Time Frame: Time through study completion, an average of 1 year ]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 to Tumor Progression (TTP) of Targeted Lesions [ Time Frame: 6 months and 1 year ]Time to tumor progression was estimated via Kaplan-Meier methodology using the 23 patients who underwent treatment.
- TTP of Nontargeted Lesions Within the Liver [ Time Frame: 1 year ]TTP of nontargeted lesions assessed via Kaplan-Meier methodology.
- Overall TTP [ Time Frame: 1 year ]Overall TTP assessed via Kaplan-Meier methodology.
- TTP Rate at 6 Months and 1 Year [ Time Frame: 6 months and 1 year ]Overall TTP assessed via Kaplan-Meier methodology at 6 months and 1 year
- Overall Survival (OS) [ Time Frame: 1 year ]OS assessed via Kaplan-Meier methodology both from initiation of therapy and from the date of diagnosis until death.
- Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 6 months ]
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.
- Response Rate - Based on Tumor Enhancement [ Time Frame: 6 months ]
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.
The overall response rate (ORR = CR + PR) was 60%. Disease control rate (DCR = CR + PR + SD) was 100%.
- Safety and Treatment Toxicity - Cycle 1 Pre-TACE [ Time Frame: Cycle 1 pre-TACE - 2 weeks ]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.
- Safety and Treatment Toxicity - Cycle 1 Post-TACE [ Time Frame: Cycle 1 post-TACE - 5 weeks ]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
- Safety and Treatment Toxicity - Cycles 2 and 3 [ Time Frame: 6 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335829
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Jeffrey F. Geschwind, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|