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Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck
This study has been completed.
First Received: July 8, 2003   Last Updated: May 9, 2009   History of Changes
Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00063895
  Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase I/II trial is studying the side effects of erlotinib and to see how well it works in treating patients with metastatic or unresectable non-small cell lung cancer, ovarian cancer, or squamous cell carcinoma (cancer) of the head and neck.


Condition Intervention Phase
Drug/Agent Toxicity by Tissue/Organ
Head and Neck Cancer
Lung Cancer
Ovarian Cancer
Drug: erlotinib hydrochloride
Procedure: management of therapy complications
Phase I
Phase II

Study Type: Interventional
Study Design: Supportive Care, Open Label
Official Title: A Pharmacogenetic and Pharmacodynamic Study of Erlotinib (OSI-774) Toxicity in Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of the CA dinucleotide repeat polymorphism in the epidermal growth factor receptor (EGFR) gene with toxicity
  • Pharmacodynamic effects

Secondary Outcome Measures:
  • Antitumor response
  • Toxicity

Study Start Date: July 2003
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Correlate the length of the CA dinucleotide repeat polymorphism in the epidermal growth factor receptor (EGFR) gene with observed toxicity in patients with advanced non-small cell lung cancer, ovarian cancer, or squamous cell carcinoma of the head and neck treated with erlotinib.
  • Determine the pharmacodynamic effects of this drug on EGFR activity and MAP kinase signaling in these patients.
  • Correlate toxicity and inhibition of EGFR phosphorylation with the area under the curve in patients treated with this drug.
  • Determine the observed antitumor response in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to length of CA dinucleotide repeat polymorphism (short vs medium vs long).

Patients receive oral erlotinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 20 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • One of the following histologically or cytologically confirmed malignancies:

    • Non-small cell lung cancer
    • Ovarian cancer
    • Squamous cell carcinoma of the head and neck
  • Metastatic or unresectable disease
  • Measurable or evaluable disease
  • No uncontrolled brain metastases

    • Previously treated brain metastases allowed provided neurologic status has been stable for at least 4 weeks after therapy and there is no neurologic dysfunction that would confound evaluation of adverse events

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

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

Hepatic

  • Bilirubin normal

Renal

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

Cardiovascular

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

Ophthalmic

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

    • Severe dry eye syndrome
    • Keratoconjunctivitis sicca
    • Sjögren's syndrome
    • Severe exposure keratopathy
    • Disorders that increase the risk for epithelium-related complications, including any of the following:

      • Bullous keratopathy
      • Aniridia
      • Severe chemical burns
      • Neutrophilic keratitis NOTE: *Patients with mild forms of the listed conditions, an asymptomatic history, or normal ophthalmologic exam may be eligible at the discretion of the investigator

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to erlotinib
  • No significant traumatic injury within the past 14 days
  • No other uncontrolled illness that would preclude study participation
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No serious nonhealing wound ulcer or bone fracture

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior biologic therapy

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • More than 14 days since prior major surgery or open biopsy

Other

  • Recovered from all prior therapy
  • At least 4 weeks since other prior investigational therapy
  • No prior small molecule epidermal growth factor receptor inhibitors, including erlotinib and gefitinib
  • No other concurrent therapy for the malignancy
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063895

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Charles M. Rudin, MD, PhD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000304628, JHOC-J0384, UCCRC-12202A, NCI-5948
Study First Received: July 8, 2003
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00063895     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
drug/agent toxicity by tissue/organ
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
recurrent ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent salivary gland cancer
stage IV salivary gland cancer
salivary gland squamous cell carcinoma
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III salivary gland cancer
stage III ovarian epithelial cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Laryngeal Carcinoma
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Squamous Cell Carcinoma
Protein Kinase Inhibitors
Hypopharyngeal Cancer
Genital Diseases, Female
Respiratory Tract Diseases
Lung Neoplasms
Ovarian Cancer
Neoplasms, Squamous Cell
Salivary Gland Diseases
Endocrine Gland Neoplasms
Erlotinib
Nasopharyngeal Carcinoma
Ovarian Neoplasms
Genital Neoplasms, Female
Carcinoma, Squamous Cell of Head and Neck
Endocrine System Diseases
Ovarian Epithelial Cancer
Recurrence
Carcinoma
Lung Diseases
Head and Neck Neoplasms
Epidermoid Carcinoma
Non-small Cell Lung Cancer
Endocrinopathy
Carcinoma, Squamous Cell

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Protein Kinase Inhibitors
Genital Diseases, Female
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Squamous Cell
Endocrine Gland Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Adnexal Diseases
Neoplasms
Lung Diseases
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009