- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055913
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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 Overview
Status
Conditions
- 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 Oropharynx
- Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Salivary Gland Squamous Cell Carcinoma
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- 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
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
Correlative studies
Given IV
Other Names:
Given orally
Other Names:
|
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.
|
Correlative studies
Given IV
Other Names:
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose of bevacizumab when used in combination with erlotinib hydrochloride determined by dose-limiting toxicities (Phase I)
Time Frame: 28 days
|
28 days
|
Objective response rate (CR + PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)
Time Frame: Up to 6 months
|
Up to 6 months
|
Progression-free survival rate (Phase II)
Time Frame: Time from the start of treatment until disease progression or death, assessed up to 7 years
|
Time from the start of treatment until disease progression or death, assessed up to 7 years
|
Overall survival rate (Phase II)
Time Frame: Up to 7 years
|
Up to 7 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tanguy Seiwert, University of Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Respiratory Tract Neoplasms
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Paranasal Sinus Diseases
- Nose Diseases
- Neoplasms, Squamous Cell
- Nasopharyngeal Neoplasms
- Nose Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Recurrence
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Oropharyngeal Neoplasms
- Laryngeal Neoplasms
- Laryngeal Diseases
- Paranasal Sinus Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Antibodies
- Erlotinib Hydrochloride
- Immunoglobulins
- Bevacizumab
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
Other Study ID Numbers
- NCI-2012-02520 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- N01CM62201 (U.S. NIH Grant/Contract)
- P30CA014599 (U.S. NIH Grant/Contract)
- CDR0000271444
- UCCRC-NCI-5701
- UCCRC-11956A
- NCI-5701
- 11956A (OTHER: University of Chicago)
- 5701 (OTHER: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Southwest Oncology GroupNational Cancer Institute (NCI)WithdrawnRecurrent 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 Oropharynx | Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal...
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