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Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma

Phase 2
18 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma

This is a phase II study to assess the proportion of subjects that remain progression-free
by the 27th week following the onset of treatment and to assess the efficacy of the
combination of Bevacizumab and Erlotinib in prolonging time to progression in subjects with
inoperable and metastatic hepatocellular carcinoma. Subjects will be treated with a
combination of rhuMAb VEGF (Bevacizumab), in combination with Erlotinib and TTP will be
assessed as per RECIST criteria. The disease will be evaluated at base line and every 9
weeks with CT scan/MRI and AFP levels. Subjects will be kept on the study till disease
progression (as defined by RECIST criteria) or death.

Inclusion Criteria:

- Subjects should have histologically or cytologically confirmed diagnosis of
hepatocellular carcinoma, regardless of biopsy site.

- Subjects with a liver mass and markedly elevated AFP (>500ng/mL) are eligible.

- Subjects should not be on the liver transplantation schedule

- Subjects can have prior therapy with sorafenib (nexavar) only if the therapy was
stopped due to toxicity or allergic reaction soon after starting. Subjects must have
been treated for less than two weeks to be eligible.

- Radiation therapy for palliation to the areas outside the site of tumor used for
measurements is permitted. If a subject has received radiation therapy to the liver,
the subject id eligible if there is a new lesion or if the prior lesion has increased
in size.

- Subjects who have recovered from prior surgical procedure

- Performance status of ECOG 0-2

- Measurable or evaluable disease

- Be declared unresectable or not suitable candidates for surgery

- Adequate organ functions

- Serum bilirubin <3 mg/dl, AST <5x ULN, ALT <5XULN

- Serum albumin >2.5 g/dl

- Serum creatinine < 2.0 mg/dl

- ANC >1200 MM3

- Platelet count >75,000/ml

- PT/INR < 1.5 X ULN

- Life expectancy of >3 months

- Subjects should be able to sign informed consent and be agreeing to comply with
therapy and follow up.

- Negative pregnancy test in women with childbearing potential, within one week prior
to initiation of treatment.

- Fertile men and women must agree to use adequate contraception prior to study entry,
for the duration of study participation, and for at least 1 week after therapy.

- Age >/= 18 years. The agents Bevacizumab and Erlotinib have not been studied in
pediatric subjects, thus the doses to be used in this study cannot be assumed to be
safe in children.

Exclusion Criteria:

- Surgically resectable disease

- Subjects with active bacterial infections

- Subjects with brain metastases

- Pregnant women (positive pregnancy test) or lactating

- No other malignancy is allowed except for adequately treated basal cell (or squamous
cell) skin cancer, in situ cervical cancer or other cancer for which the subject has
been disease-free for five years.

- Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sjogren's
syndrome) or congenital abnormality (e.g. Fuch's dystrophy).

- Current, recent (within 4 weeks of the first infusion of the study), or planned
participation in an experimental drug study other than a Genentech-sponsored
Bevacizumab/Erlotinib cancer study

- Hepatic encephelopathy (as per treating physician's evaluation)

- Uncontrolled blood Pressure >150/100 mmHg

- Unstable angina

- NYHA grade II or greater congestive heart failure

- History or myocardial infraction within 6 months

- History of stroke within 6 months

- Clinically significant peripheral vascular disease (clinically significant venous or
arterial thrombotic disease).

- Evidence of bleeding diathesis or coagulopathy

- Urine protein: creatinine ratio >1.0 at screening

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0

- Serious, non-healing wound, ulcer, or bone fracture

- Inability to comply with study and/or follow-up procedures

- Gastrointestinal disease resulting in an inability to take oral medication or a
requirement for intravenous hyperalimentation.

- History of significant gastrointestinal bleeding requiring procedural intervention
(e.g. variceal banding, TIPS procedure, arterial embolization, topical coagulation
therapy) within six months prior to study Day 0.

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, or anticipation of need for major surgical procedure during the
course of the study.

- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to Day 0

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Who Remained Free of Progression at the 27th Week.

Outcome Time Frame:

27 weeks

Safety Issue:


Principal Investigator

Rangaswamy Govindarajan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Food and Drug Administration

Study ID:

UARK 2005-13



Start Date:

February 2006

Completion Date:

September 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Inoperable and Metastatic Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular



University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas University Medical CenterKansas City,, Kansas  66160-7390