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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of bevacizumab when used in combination with erlotinib hydrochloride determined by dose-limiting toxicities (Phase I)

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Ezra Cohen

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02520

NCT ID:

NCT00055913

Start Date:

March 2003

Completion Date:

Related Keywords:

  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470