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| ID | Type | Description | Link |
|---|---|---|---|
| JHOC-J0598 | |||
| JHOC-NA_00001249 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Northwestern University | OTHER |
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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
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm, received bevacizumab and TACE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological |
| ||
| chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | 6 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| TTP of Nontargeted Lesions Within the Liver | TTP of nontargeted lesions assessed via Kaplan-Meier methodology. | 1 year |
| Overall TTP | Overall TTP assessed via Kaplan-Meier methodology. |
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DISEASE CHARACTERISTICS:
Histologically confirmed* hepatocellular carcinoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey F. Geschwind, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
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Patients with a diagnosis of unresectable hepatocellular carcinoma (HCC) were enrolled on this protocol to receive a combination of intravenous bevacizumab and transarterial chemoembolization (TACE) therapy. A total of 26 patients were enrolled on protocol; 10 patients at Northwestern University and 16 at Johns Hopkins University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm, Received Bevacizumab and TACE | Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm, Received Bevacizumab and TACE | bevacizumab chemotherapy embolization therapy hepatic artery infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | PFS analysis was not conducted. No data were collected for this Outcome Measure | Posted | Time through study completion, an average of 1 year |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm, Received Bevacizumab and TACE | bevacizumab chemotherapy embolization therapy hepatic artery infusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clostridium difficile infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Geschwind, MD | Johns Hopkins, Interventional Radiology | 410-614-6597 | jfg@jhmi.edu |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D004358 | Drug Therapy |
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
|
| embolization therapy | Drug |
|
| hepatic artery infusion | Procedure |
|
| 1 year |
| TTP Rate at 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) | 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) | 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 | 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 | 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 | 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 | 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Primary | 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. | Posted | Number | months | 6 months and 1 year |
|
|
|
| Secondary | TTP of Nontargeted Lesions Within the Liver | TTP of nontargeted lesions assessed via Kaplan-Meier methodology. | Posted | Median | 95% Confidence Interval | months | 1 year |
|
|
|
| Secondary | Overall TTP | Overall TTP assessed via Kaplan-Meier methodology. | Posted | Median | 95% Confidence Interval | months | 1 year |
|
|
|
| Secondary | TTP Rate at 6 Months and 1 Year | Overall TTP assessed via Kaplan-Meier methodology at 6 months and 1 year | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months and 1 year |
|
|
|
| Secondary | Overall Survival (OS) | OS assessed via Kaplan-Meier methodology both from initiation of therapy and from the date of diagnosis until death. | Posted | Median | 95% Confidence Interval | months | 1 year |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Posted | Number | adverse events | Cycle 1 pre-TACE - 2 weeks | Adverse events | Adverse events |
|
|
|
| Secondary | 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 | 1 out of the initial 26 patients did not complete the first TACE on protocol and was not included in this assessment. | Posted | Number | adverse events | Cycle 1 post-TACE - 5 weeks | Adverse events | Adverse events |
|
|
|
| Secondary | 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 | 14 out of the original 26 study participants completed 2 or 3 cycles of TACE and bevacizumab therapy - adverse events associated with these patients for cycles 2 and 3 assessed. | Posted | Number | adverse events | 6 months | Adverse events | Adverse events |
|
|
|
| 1 |
| 26 |
| 6 |
| 26 |
| 26 |
| 26 |
| Cerebral infarct | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Liver failure | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Esophageal varices | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Coagulation/Elevated INR | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatologic | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Endocrine | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated ALT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Elevated AST | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Psychosis | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right upper quadrant pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
| D006489 | Hemostatic Techniques |
| D060205 | Therapeutic Occlusion |
| Title | Measurements |
|---|---|
|
| Progressive Disease (PD) |
|
| Overall response rate (CR + PR) |
|
| Disease control rate (CR + PR + SD) |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease (PD) |
|
| Overall response rate (CR + PR) |
|
| Disease control rate (CR + PR + SD) |
|
| Title | Measurements |
|---|---|
|
| Ascites |
|
| Anorexia |
|
| Nausea |
|
| Vomiting |
|
| Esophageal varices |
|
| Elevated ALT |
|
| Elevated AST |
|
| Hyperbilirubinemia |
|
| Hyponatremia |
|
| Encephalopathy |
|
| Right upper quadrant pain |
|
| Proteinuria |
|
| Respiratory |
|
| Title | Measurements |
|---|---|
|
| Edema |
|
| Ischemia |
|
| Coagulation |
|
| Fatigue |
|
| Night sweats |
|
| Weight loss |
|
| Ascites |
|
| Anorexia |
|
| Nausea |
|
| Vomiting |
|
| HEENT |
|
| Elevated ALT |
|
| Elevated AST |
|
| Hyperbilirubinemia |
|
| Liver failure |
|
| Cellulitis |
|
| Colangitis |
|
| Hyperglycemia |
|
| Hypocalcemia |
|
| Hypokalemia |
|
| Hyponatremia |
|
| Delirium |
|
| Psychosis |
|
| Abdominal pain, not otherwise specified (NOS) |
|
| Epigastric pain |
|
| Right upper quadrant pain |
|
| Chest pain |
|
| Pain - other |
|
| Dyspnea |
|
| Acute renal failure |
|
| Proteinuria |
|
| Respiratory |
|
| Title | Measurements |
|---|---|
|
| Edema |
|
| Coagulation |
|
| Fatigue |
|
| Weight loss |
|
| Dermatologic |
|
| Endocrine |
|
| Ascites |
|
| Anorexia |
|
| Duodenal perforation |
|
| Nausea |
|
| Vomiting |
|
| Elevated ALT |
|
| Elevated AST |
|
| Hyperbilirubinemia |
|
| Clostridium difficile |
|
| Hyperglycemia |
|
| Hypocalcemia |
|
| Hypokalemia |
|
| Hyponatremia |
|
| Fracture |
|
| Cord compression |
|
| Stroke |
|
| Right upper quadrant pain |
|
| Pain - other |
|
| Dyspnea |
|
| Proteinuria |
|
| Respiratory |
|