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Phase 2 N=27 Treatment

Bevacizumab and Erlotinib in Treating Patients With Advanced Liver Cancer

Adult Primary Hepatocellular Carcinoma · Advanced Adult Primary Liver Cancer · Localized Unresectable Adult Primary Liver Cancer · Recurrent Adult Primary Liver Cancer

Enrolled (actual)
27
Serious AEs
51.8%
Results posted
Jul 2013
Primary outcome: Primary: Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR). — 0; 1 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
bevacizumab (Biological); erlotinib hydrochloride (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Aug 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR).
0; 1
SECONDARY
Survival Time
9.5
SECONDARY
Time to Disease Progression
3.0
SECONDARY
Duration of Response
SECONDARY
Time to Treatment Failure
2.0

Summary

This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with advanced liver cancer. 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. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and erlotinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with erlotinib may kill more tumor cells

Eligibility Criteria

Inclusion Criteria

  • Absolute neutrophil count >= 1,500/mm^3
  • Creatinine = = 2.5 g/dL
  • Total bilirubin = = 6 months after completion of study treatment
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study and for >= 6 months after completion of study treatment
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab or erlotinib hydrochloride
  • No abnormalities of the cornea, including any of the following:

History of dry eye syndrome or Sjögren's syndrome; Congenital abnormality (e.g., Fuch's dystrophy); Abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose); Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)

  • No stroke or transient ischemic attack within the past 6 months
  • No uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
  • No unstable angina pectoris within the past 6 months
  • No symptomatic congestive heart failure
  • No myocardial infarction within the past 6 months
  • No serious uncontrolled cardiac arrhythmias
  • No uncontrolled diabetes mellitus
  • No active or uncontrolled infection
  • No impaired GI function or disease that may significantly alter the absorption of erlotinib hydrochloride (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or bowel obstruction)
  • Able to swallow tablets
  • No psychiatric illness or social situation that would limit compliance with study requirements
  • No history of nephrotic-range protein
  • No history of bleeding diathesis
  • No encephalopathy
  • No serious nonhealing wounds, skin ulcers, or bone fractures
  • No clinically significant peripheral vascular disease
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No history of a GI bleed that required procedural intervention (e.g., variceal banding, surgical shunt, transvenous intrahepatic porto-systemic shunt [TIPS]) within the past 3 months
  • No significant traumatic injury within the past 28 days
  • No other prior malignancy within the past 5 years except for the following:

Adequately treated basal cell or squamous cell skin cancer; Adequately treated in situ cervical cancer; Stage I or II cancer from which the patient is currently in complete remission; Stage I chronic lymphocytic leukemia

  • Recovered from all therapy-related toxicities
  • No more than 1 prior systemic or liver directed drug therapy including transarterial chemoembolization (TACE) (multiple TACEs will count as 1 prior regimen irrespective of their total numbers) that were used for HCC
  • No chemotherapy for HCC within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
  • No biological therapy or immunotherapy for HCC within the past 4 weeks
  • Prior surgery, regional therapy (e.g., transarterial embolization), liver transplantation, or other liver-directed ablative therapies of discrete lesions allowed provided any related progressive or recurrent disease is documented
  • No cryotherapy, radiofrequency ablation, ethanol injection, or photodynamic therapy within the past 6 weeks:

Indicator lesions must be outside the area of prior treatment OR if the lesion is inside the area of prior treatment, there must be clear evidence of disease progression associated with that lesion

  • No core biopsy within the past 7 days
  • No radiotherapy within the past 4 weeks
  • No prior antiangiogenesis agent or antiepidermal growth factor receptor drug
  • No prior treatment with hepatic arterial infusion with chemotherapy or yttrium Y 90-labeled microspheres
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  • Concurrent full-dose anticoagulants (e.g., warfarin) with international normalized ratio (INR) > 1.2 allowed provided the f
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00365391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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