- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00335829
Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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) < 5.0 times upper limit of normal (ULN)
- Bilirubin ≤ 5.0 mg/dL
- Creatinine normal OR creatinine clearance > 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single arm, received bevacizumab and TACE
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 through study completion, an average of 1 year
|
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.
|
6 months and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TTP of Nontargeted Lesions Within the Liver
Time Frame: 1 year
|
TTP of nontargeted lesions assessed via Kaplan-Meier methodology.
|
1 year
|
Overall TTP
Time Frame: 1 year
|
Overall TTP assessed via Kaplan-Meier methodology.
|
1 year
|
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
|
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.
|
1 year
|
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. |
6 months
|
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. |
6 months
|
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.
|
Cycle 1 pre-TACE - 2 weeks
|
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
|
Cycle 1 post-TACE - 5 weeks
|
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
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- J0598 CDR0000483104
- JHOC-J0598
- JHOC-NA_00001249
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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