Clinical trial NCT00335829: Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Official title: Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Keywords: localized unresectable adult primary liver cancer
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
recurrent adult primary liver cancer
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Northwestern University
First posted: 2006-06-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Median Progression-free Survival
timeFrame: Time through study completion, an average of 1 year
measure: Time to Tumor Progression (TTP) of Targeted Lesions
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: TTP of Nontargeted Lesions Within the Liver
timeFrame: 1 year
measure: Overall TTP
timeFrame: 1 year
measure: TTP Rate at 6 Months and 1 Year
timeFrame: 6 months and 1 year
measure: Overall Survival (OS)
timeFrame: 1 year
measure: Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 6 months
measure: Response Rate - Based on Tumor Enhancement
timeFrame: 6 months
measure: Safety and Treatment Toxicity - Cycle 1 Pre-TACE
timeFrame: Cycle 1 pre-TACE - 2 weeks
measure: Safety and Treatment Toxicity - Cycle 1 Post-TACE
timeFrame: Cycle 1 post-TACE - 5 weeks
measure: Safety and Treatment Toxicity - Cycles 2 and 3
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Jeffrey F. Geschwind, MD
role: STUDY_CHAIR
References: