NCT00365391

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

July 10, 2013

Completed
Last Updated

July 9, 2015

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

August 16, 2006

Results QC Date

March 22, 2013

Last Update Submit

June 10, 2015

Conditions

Adult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerRecurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR).

    Responses to erlotinib and bevacizumab treatment were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters.

    Patients were able to continue treatment indefinitely and were evaluated every cycle until discontinued treatment.

Secondary Outcomes (4)

  • Survival Time

    From registration to death due to any cause, patients are followed up to 3 years after treatment

  • Time to Disease Progression

    From registration to documentation of disease progression, up to 3 years after treatment.

  • Duration of Response

    The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.

  • Time to Treatment Failure

    From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.

Study Arms (1)

Treatment (monoclonal antibody, enzyme inhibitor)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.

Biological: bevacizumabDrug: erlotinib hydrochloride

Interventions

bevacizumabBIOLOGICAL

Given IV, 10 mg/kg, days 1 and 15 in every cycle

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Treatment (monoclonal antibody, enzyme inhibitor)
erlotinib hydrochlorideDRUG

Given orally, 150 mg, every day during each cycle.

Also known as: CP-358,774, erlotinib, OSI-774
Treatment (monoclonal antibody, enzyme inhibitor)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Absolute neutrophil count \>= 1,500/mm\^3
  • Creatinine =\< 2 mg/dL
  • Albumin \>= 2.5 g/dL
  • Total bilirubin =\< upper limit of normal (ULN)
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 times ULN
  • Alkaline phosphatase =\< 5 times ULN
  • Urine protein:creatinine ratio \< 1.0 OR 24-hour urine protein \< 1,000 mg
  • Not pregnant or nursing:
  • No nursing for \>= 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
  • +53 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Philip PA, Mahoney MR, Holen KD, Northfelt DW, Pitot HC, Picus J, Flynn PJ, Erlichman C. Phase 2 study of bevacizumab plus erlotinib in patients with advanced hepatocellular cancer. Cancer. 2012 May 1;118(9):2424-30. doi: 10.1002/cncr.26556. Epub 2011 Sep 27.

    PMID: 21953248DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

BevacizumabErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Philip A. Philip, M.D., Ph.D., F.R.C.P.
Organization
Wayne State University
philipp@karmanos.org

Study Officials

  • Philip Philip

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

August 1, 2006

Primary Completion

August 1, 2008

Study Completion

June 1, 2010

Last Updated

July 9, 2015

Results First Posted

July 10, 2013

Record last verified: 2013-03

Locations

US(1)