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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030576
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 10, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in treating patients who have recurrent or metastatic head and neck cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: cisplatin Drug: erlotinib hydrochloride Phase 1 Phase 2

Detailed Description:


  • Determine the objective response rate in patients with recurrent or metastatic squamous cell cancer of the head and neck treated with erlotinib and cisplatin.
  • Determine the stable disease rates, duration of response, progression-free survival, median survival, and overall survival of patients treated with this regimen.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the relationship between clinical, pharmacokinetic, and pharmacodynamic effects of this regimen in these patients.
  • Correlate baseline and post-treatment levels of epidermal growth factor receptor, its downstream signaling components, and markers of angiogenesis and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral erlotinib once daily on days -6 to 21 for the first course only and cisplatin IV over 60 minutes on day 1. For the second and subsequent courses, patients receive oral erlotinib once daily on days 1-21 and cisplatin as in course 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after 6 courses may continue to receive erlotinib alone until disease progression.

Cohorts of 3-6 patients receive escalating doses of erlotinib and cisplatin 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. At least 6 patients are treated at the MTD.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A maximum of 43 patients will be accrued for this study within 18 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study Of OSI-774 In Combination With Cisplatin In Patients With Recurrent Or Metastatic Squamous Cell Cancer Of The Head And Neck
Actual Study Start Date : November 2001
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: OSI-774 and cisplatin
HNSCC patients treated in three escalating dose cohorts of daily continous oral erlotinib (OSI-774) and intermittent IV cisplatin given every 21 days
Drug: cisplatin
Drug: erlotinib hydrochloride

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed squamous cell carcinoma of the head and neck

    • All primary sites, including oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus
  • Recurrent, unresectable, and/or metastatic disease
  • At least 1 measurable lesion

    • At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan
  • Lesions accessible for biopsy
  • Tumor specimen available for evaluation of epidermal growth factor receptor (EGFR) expression
  • No known brain metastases



  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • More than 12 weeks


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • No gastrointestinal tract disease resulting in malabsorption
  • No requirement for IV alimentation
  • No active peptic ulcer disease
  • Inability to swallow tablets or silicon-based G-tubes allowed


  • No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjogren's syndrome)
  • No congenital abnormality (e.g., Fuch's dystrophy)
  • No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
  • No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix, nonmelanoma skin cancer, or second primary squamous cell cancer originating from the head and neck
  • No grade 2 or greater residual ototoxicity or neuropathy from prior platinum-based therapy
  • No significant traumatic injury within the past 21 days
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation


Biologic therapy:

  • Not specified


  • No prior chemotherapy for recurrent or metastatic disease
  • Prior platinum-based chemotherapy with radiotherapy or platinum-based induction chemotherapy allowed
  • At least 6 months since prior chemotherapy

Endocrine therapy:

  • Not specified


  • See Chemotherapy
  • At least 4 weeks since prior radiotherapy (except low-dose, limited-fraction palliative non-myelosuppressive radiotherapy [e.g., involving less than 20% of functioning bone marrow using 800 cGy in 1 fraction or 2,000 cGy in 5 fractions]) and recovered
  • No prior radiotherapy to target lesion unless there is evidence of disease progression


  • See Disease Characteristics
  • At least 21 days since prior major surgery
  • No prior surgical procedure affecting gastrointestinal absorption


  • No prior EGFR-targeting therapies
  • No prior investigational agents for recurrent or metastatic disease
  • No concurrent combination anti-retroviral therapy for HIV infection
  • No other concurrent investigational agents
  • No other concurrent anticancer treatment

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 identifier (NCT number): NCT00030576

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Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
Sponsors and Collaborators
University Health Network, Toronto
National Cancer Institute (NCI)
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Study Chair: Lillian L. Siu, MD, FRCPC Princess Margaret Hospital, Canada
Study Chair: Elizabeth A. Eisenhauer, MD Cancer Research Institute at Queen's University

Publications of Results:
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Responsible Party: University Health Network, Toronto Identifier: NCT00030576    
Other Study ID Numbers: CDR0000069178 (PHL-002)
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Health Network, Toronto:
recurrent metastatic squamous neck cancer occult primary
neck cancer with occult primary squamous carcinoma
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
squamous cell carcinoma of paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of sinus and nasal cavity
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action