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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 8, 2006

Last Updated Date

April 3, 2009

Start Date ^†

May 2006

Current Primary Outcome Measures ^†

Median progression-free survival [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00335829 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Safety [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]
Response rate [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Safety
Toxicity
Response rate

Descriptive Information

Brief Title ^†

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label

Condition ^†

Liver Cancer

Intervention ^†

Biological: bevacizumab
Drug: chemotherapy
Drug: embolization therapy
Procedure: hepatic artery infusion

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Estimated Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

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:

ECOG performance status 0-2
Absolute neutrophil count > 1,500/mm³
Platelet count > 50,000/mm³
AST and 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00335829

Responsible Party

Jeffrey F. Geschwind, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Secondary IDs ^††

JHOC-J0598, JHOC-NA_00001249

Study Sponsor ^†

Sidney Kimmel Comprehensive Cancer Center

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Jeffrey F. Geschwind, MD

Sidney Kimmel Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.