Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer

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Brief Title

Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer

Official Title

A Phase I Clinical and Biological Evaluation of Combined EGFR Blockade With Erlotinib and Cetuximab in Patients With Advanced Cancer

Brief Summary

      This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when
      given together with cetuximab and to see how well they work in treating patients with
      advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or
      colorectal cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking
      some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, 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 hydrochloride and cetuximab may also stop the growth of tumor cells by blocking
      blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more
      tumor cells.

Detailed Description


      I. To identify the maximum tolerated dose (MTD). II. To identify the recommended dose (RD)
      for phase II of erlotinib (erlotinib hydrochloride) in combination with cetuximab in patients
      (pts) with incurable gastrointestinal, head and neck, or non-small cell lung cancers that are
      Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type.


      I. To identify dose-limiting toxicities (DLT). II. To perform skin and tumor biopsies to
      analyze molecular inhibition of the epidermal growth factor receptor (EGFR) signaling
      pathway, defined as a >= 75% inhibition of phosphorylation of the epidermal growth factor
      (EGF) receptor or of its downstream effectors tumor protein (p)44/42 mitogen-activated
      protein kinase (MAPK) or protein kinase B (Akt) or as a >= 25% decrease of marker of
      proliferation Ki-67 (Ki67) from baseline in either skin or tumor tissue in the majority of

      III. To identify the optimal biological dose (OBD). IV. To describe any antitumor effect

      OUTLINE: This is a phase I, dose-escalation study of erlotinib hydrochloride.

      Patients receive cetuximab intravenously (IV) over 1-2 hours on days 1, 8, and 15 and
      erlotinib hydrochloride orally (PO) once daily (QD) on days 8-21. Treatment repeats every 21
      days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed for 4 weeks.

Study Phase

Phase 1

Study Type


Primary Outcome

Incidence of DLT, defined as recurring grade 2 or greater non-hematological or grade 3 or greater hematological toxicities or skin rash graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE-v3)

Secondary Outcome

 Change in molecular inhibition of the EGFR signaling pathway


Adenocarcinoma of the Colon



Study Arms / Comparison Groups

 Treatment (cetuximab and erlotinib hydrochloride)
Description:  Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and erlotinib hydrochloride PO QD on days 8-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

January 2007

Completion Date

June 2013

Primary Completion Date

June 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed incurable
             gastrointestinal tract, head and neck, or non-small cell lung cancers that are KRAS
             wild type; if KRAS mutational status cannot be determined on archived tumor tissue
             from the patient, a needle or excisional biopsy of a malignant site may be performed
             prior to enrollment; mutational status may be determined either by polymerase chain
             reaction (PCR) assay (e.g., DxS KRAS mutation kit) or by direct sequencing of KRAS
             exon 2, codons 12 and 13; the result must detect no mutations at these sites

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 X institutional upper limit of normal

          -  Creatinine within normal institutional limits or creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Eligibility of patients receiving any medications or substances known to affect or
             with the potential to affect the activity or pharmacokinetics of erlotinib will be
             determined following review of their case by the principal investigator; although
             concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
             inducers is not prohibited in this study, identification of MTD and DLT may be
             affected by their use; concomitant use of any of these drugs will be noted in the case
             report forms and will be taken into account in determining MTD and DLT of this
             therapy; efforts should be made to switch patients with a history of brain metastases
             who are taking enzyme-inducing anticonvulsant agents to other medications

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician

          -  Other prior malignancies are allowed provided prior therapy has been discontinued and
             there is no evidence of disease (NED)

          -  Patients must be able to take and retain oral medications

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 4 weeks earlier

          -  Patients may not be receiving any other investigational agents

          -  Patients with a history of brain metastases are eligible provided that the metastases
             have been surgically resected and/or are radiographically and clinically stable for 2
             months following the completion of radiation therapy

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to erlotinib

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to cetuximab

          -  Prior treatment with EGFR-targeting therapies

          -  Major surgery or significant traumatic injury occurring within 21 days prior to

          -  Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's
             syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp
             examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or an abnormal
             corneal sensitivity test (Schirmer test or similar tear production test)

          -  Gastrointestinal tract disease resulting in an inability to take oral medication or a
             requirement for IV alimentation, prior surgical procedures affecting absorption, or
             active peptic ulcer disease

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with erlotinib or cetuximab

          -  Human immunodeficiency virus (HIV)-positive patients receiving combination
             anti-retroviral therapy are excluded from the study




18 Years - N/A

Accepts Healthy Volunteers



Laura Goff, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Laura Goff, Principal Investigator, Vanderbilt-Ingram Cancer Center

Verification Date

February 2014