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Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00335829
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Northwestern University
Information provided by (Responsible Party):
Jeff Geschwind, Yale University

Brief 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.


Condition or disease Intervention/treatment Phase
Liver Cancer Biological: bevacizumab Drug: chemotherapy Drug: embolization therapy Procedure: hepatic artery infusion Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: single arm, received bevacizumab and TACE Biological: bevacizumab
Drug: chemotherapy
Drug: embolization therapy
Procedure: hepatic artery infusion



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. TTP of Nontargeted Lesions Within the Liver [ Time Frame: 1 year ]
    TTP of nontargeted lesions assessed via Kaplan-Meier methodology.

  2. Overall TTP [ Time Frame: 1 year ]
    Overall TTP assessed via Kaplan-Meier methodology.

  3. 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

  4. 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.

  5. 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. 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%.


  7. 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.

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) < 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

Information from the National Library of Medicine

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


Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Northwestern University
Investigators
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Study Chair: Jeffrey F. Geschwind, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Jeff Geschwind, Professor of Radiology and Oncology, Yale University
ClinicalTrials.gov Identifier: NCT00335829     History of Changes
Other Study ID Numbers: J0598 CDR0000483104
JHOC-J0598
JHOC-NA_00001249
First Posted: June 12, 2006    Key Record Dates
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017
Last Verified: July 2017

Keywords provided by Jeff Geschwind, Yale University:
localized unresectable adult primary liver cancer
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors