CompletedPhase 2

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

United States26 participantsStarted 2006-05

Plain-language 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.

Who can participate

Age range18 Years – 120 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Median Progression-free Survival

Timeframe: Time through study completion, an average of 1 year

Time to Tumor Progression (TTP) of Targeted Lesions

Timeframe: 6 months and 1 year

Trial details

NCT IDNCT00335829

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-02

Results submitted2017-04-19