Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Met… (NCT00867321) | Clinical Trial Compass
CompletedPhase 1/2
Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
United States24 participantsStarted 2009-04
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. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
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 or cytologically confirmed hepatocellular carcinoma
* Locally advanced or metastatic disease that is not amenable to treatment with surgery or to orthotopic liver transplant
* Child Pugh class A or B7 disease
* Measurable disease
* No mixed cholangiocarcinoma/hepatocellular carcinoma
* No current or previously resected brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* ANC ≥ 1,200/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 5 times ULN
* Alkaline phosphatase ≤ 5 times ULN
* Urine protein ≤ 1+ by urine protein:creatinine ratio OR 24-hour urine protein \< 1 g
* QTc interval ≤ 500 msec on baseline EKG
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 2 weeks after sorafenib tosylate and 6 months after bevacizumab
* None of the following risk factors for decreased LVEF:
* Prior treatment with anthracyclines
* History of myocardial infarction within the past 12 months
* No uncontrolled hypertension (defined as systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management
* No New York Heart Association class III-IV congestive heart failure
* No cardiac ventricular arrhythmias requiring antiarrhythmic therapy
* No history of hypertensive crisis or hypertensive encephalopathy
* No ca…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (Phase I)
Timeframe: From baseline up to 3 years post treatment
2
Time to Progression (TTP) (Phase II)
Timeframe: From baseline up to 3 years post treatment