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Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00055913
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
This randomized phase I/II trial is to see if combining erlotinib with bevacizumab works better in treating patients who have recurrent or metastatic head and neck cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes needed for tumor cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining erlotinib with bevacizumab may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous Cell Carcinoma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Oropharynx Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Salivary Gland Squamous Cell Carcinoma Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IV Squamous Cell Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IV Squamous Cell Carcinoma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Oropharynx Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Biological: bevacizumab Drug: erlotinib hydrochloride Other: laboratory biomarker analysis Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose and dose-limiting toxicity of bevacizumab when administered with erlotinib in patients with recurrent or metastatic head and neck cancer.

II. Determine the objective response rate and stable disease/absence of early progression in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of bevacizumab followed by a randomized, multicenter study.

Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Phase II: Course 1 is 28 days in length. All subsequent courses are 21 days.

Course 1: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on days 1-28.

Arm II: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-28.

All subsequent courses: All patients receive bevacizumab as in arm II and oral erlotinib on days 1-21.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study Of Bevacizumab (rhuMAb VEGF) In Combination With OSI-774 For Patients With Recurrent Or Metastatic Cancer Of The Head And Neck
Study Start Date : March 2003
Actual Primary Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on days 1-28. All subsequent courses patients receive oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
 Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF

Drug: erlotinib hydrochloride
Given orally
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774

Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-28. All subsequent courses patients receive oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
 Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF

Drug: erlotinib hydrochloride
Given orally
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose of bevacizumab when used in combination with erlotinib hydrochloride determined by dose-limiting toxicities (Phase I) [ Time Frame: 28 days ]
  2. Objective response rate (CR + PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II) [ Time Frame: Up to 6 months ]
  3. Progression-free survival rate (Phase II) [ Time Frame: Time from the start of treatment until disease progression or death, assessed up to 7 years ]
  4. Overall survival rate (Phase II) [ Time Frame: Up to 7 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed squamous cell cancer of the head and neck

    • Recurrent or metastatic disease
    • Determined to be incurable by surgery or radiotherapy
  • Measurable disease
  • No tumor involvement encasing or too close in proximity to a major artery or vein
  • No known brain metastases
  • No prior or concurrent CNS disease
  • No primary brain tumor
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 12 weeks
  • No history of bleeding diathesis
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • INR less than 1.5
  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal
  • Creatinine normal
  • Creatinine clearance at least 60 mL/min
  • No significant renal impairment
  • 24-hour urinary protein less than 0.5 g required if more than trace proteinuria at baseline
  • No uncontrolled hypertension
  • No symptomatic congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No deep venous thrombosis
  • No prior stroke
  • No New York Heart Association class II-IV heart disease
  • No grade II-IV peripheral vascular disease within the past year

  • No arterial thromboembolic event within the past 6 months, including any of the following:

    • Unstable angina pectoris
    • Myocardial infarction
    • Transient ischemic attack
    • Cerebrovascular accident
  • No clinically significant peripheral artery disease

  • No significant ophthalmologic abnormalities* including any of the following:

    • Severe dry eye syndrome
    • Keratoconjunctivitis sicca
    • Sjögren's syndrome
    • Severe exposure keratopathy
    • Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reactions to compounds of similar chemical or biologic composition to bevacizumab or other study agents
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No significant traumatic injury within the past 28 days
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • No ongoing or active infection requiring parenteral antibiotics
  • No serious non-healing wound ulcer or bone fracture
  • No seizures not controlled by standard medical therapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • More than 4 weeks since prior radiotherapy
  • More than 4 weeks since prior major surgery
  • More than 4 weeks since prior open biopsy
  • Recovered from prior therapy
  • No more than 1 prior regimen for recurrent disease
  • No prior epidermal growth factor receptor (EGFR)-based therapy for recurrent disease
  • No prior vascular EGFR-based therapy for recurrent disease
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent chronic use of aspirin (325 mg/day or more) or other nonsteroidal anti-inflammatory drugs
  • No concurrent warfarin or heparin, including low-molecular weight heparin
  • No other concurrent or recent (within 1 month) thrombolytic agents or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055913


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tanguy Seiwert University of Chicago
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00055913     History of Changes
Other Study ID Numbers: NCI-2012-02520
NCI-2012-02520 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000271444
UCCRC-NCI-5701
UCCRC-11956A
NCI-5701
11956A ( Other Identifier: University of Chicago )
5701 ( Other Identifier: CTEP )
P30CA014599 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Nasopharyngeal Carcinoma
Paranasal Sinus Neoplasms
Laryngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
 Neoplasms by Site
Respiratory Tract Neoplasms
Pharyngeal Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Nasopharyngeal Neoplasms
Nasopharyngeal Diseases
Nose Neoplasms
Nose Diseases
Paranasal Sinus Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Erlotinib Hydrochloride
Antibodies
Immunoglobulins