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

NCT00335829 | Completed Phase 2 Results DMC

• 3 other identifiers: J0598 CDR0000483104JHOC-J0598JHOC-NA_00001249
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver cancer; adult primary hepatocellular carcinoma; advanced adult primary liver cancer; recurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• TTP of Nontargeted Lesions Within the Liver

  1 year

• Overall TTP

  1 year

• TTP Rate at 6 Months and 1 Year

  6 months and 1 year

• Overall Survival (OS)

  1 year

• Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)

  6 months

Study Arms (1)

single arm, received bevacizumab and TACE

EXPERIMENTAL

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

Interventions

bevacizumab BIOLOGICAL

single arm, received bevacizumab and TACE

chemotherapy DRUG

single arm, received bevacizumab and TACE

embolization therapy DRUG

single arm, received bevacizumab and TACE

hepatic artery infusion PROCEDURE

single arm, received bevacizumab and TACE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator
• Northwestern University: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Bevacizumab; Drug Therapy; Embolization, Therapeutic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics; Hemostatic Techniques; Therapeutic Occlusion

Results Point of Contact

• Title: Jeff Geschwind, MD
• Organization: Johns Hopkins, Interventional Radiology

jfg@jhmi.edu

410-614-6597

Study Officials

• Jeffrey F. Geschwind, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 12, 2006
• Study Start: May 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 13, 2021
• Results First Posted: August 28, 2017

Record last verified: 2021-08

Locations

US (1)