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NCT Number: NCT00335829

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

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.

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Key information

Conditions

Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Biological

Chemotherapy

Drug

Embolization Therapy

Drug

hepatic artery infusion

Procedure

Primary outcomes

  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 outcomes

  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.

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Cancer Institute (NCI)
  • Northwestern University

Registry information

Official study title

Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jun 12, 2006
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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