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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck

A Pharmacogenetic and Pharmacodynamic Study of Erlotinib (OSI-774) Toxicity in Patients With Advanced Solid Tumors

NCT00063895•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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

Detailed Description

PRIMARY OBJECTIVES: I. To determine if a significant correlation exists between the length of the CA dinucleotide repeat polymorphism in the EGFR gene and observed toxicity in patients treated with OSI-774. SECONDARY OBJECTIVES: I. To study the pharmacodynamic effects of OSI-774 on EGFR activity and MAP kinase signaling using skin as a surrogate tissue. II. To determine if interindividual variation of OSI-774 pharmacokinetics is related to a previously described CYP3A5 genetic polymorphism. III. To evaluate whether toxicity or inhibition of EGFR phosphorylation correlates with OSI-774 AUC in patients treated with OSI-774. IV. To describe the observed anti-tumor response and toxicities in patients with advanced solid tumors treated with single agent fixed dose of OSI-774. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed metastatic or unresectable non-small cell lung cancer, squamous cell carcinoma of the head and neck, or ovarian cancer
•Eligible patients must have been off previous anticancer therapy including chemotherapy, radiotherapy, biological therapy, or other investigational therapy for at least 4 weeks before study entry (6 weeks if prior therapy included nitrosoureas or mitomycin C)
•ECOG performance status =\< 2 (Karnofsky \>= 60%)
•Life expectancy of greater than 12 weeks
•Leukocytes \>= 3,000/ul
•Absolute neutrophil count \>= 1,500/ul
•Platelets \>= 100,000/ul
•Total bilirubin within normal institutional limits
•Creatinine within normal institutional limits OR creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
•Patients must have measurable or assessable disease
+2 more criteria

Exclusion Criteria

•Patients may not be receiving any other investigational agents
•Patients with uncontrolled brain metastasis; patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 4 weeks, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774
•Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Pregnant women are excluded from this study because OSI-774 is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with either agent
•HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
•Patients with significant ophthalmologic abnormalities, including: severe dry eye syndrome, kerato-conjunctivitis sicca, Sjogren'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); patients with mild forms of any of the above, an asymptomatic history, or a normal ophthalmologic examination may be considered for inclusion at the discretion of the investigator; an ophthalmologic exam is not needed prior to this study unless clinically indicated; patients with treatable conditions (e.g. infectious keratitis/conjunctivitis, allergic conjunctivitis) may be reevaluated for study eligibility after treatment or resolution of the condition; use of contact lenses during the course of this trial may increase the risk of corneal complications and will be strongly discouraged
•Serious, non-healing wound ulcer, or bone fracture
•Major surgical procedure, open biopsy or significant traumatic injury within 14 days prior to Day 1; following such procedures or injuries, wound healing should be evident prior to initiation of therapy

Locations (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Key Dates

Start Date

April 1, 2003

Primary Completion Date

October 1, 2005

Last Updated

January 9, 2013

Enrollment

ESTIMATED participants

Conditions

Recurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage IIIA Non-small Cell Lung CancerStage IIIA Ovarian Epithelial CancerStage IIIB Non-small Cell Lung CancerStage IIIB Ovarian Epithelial CancerStage IIIC Ovarian Epithelial CancerStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the Oropharynx

Interventions

erlotinib hydrochloride

DRUG

pharmacological study

OTHER

pharmacogenomic studies

OTHER

laboratory biomarker analysis

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

Exclusion Criteria

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

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