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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
erlotinib hydrochloride
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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, 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, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck Metastatic and/or locally recurrent disease No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations, as well as tumors of the parotid gland WHO Type I squamous cell carcinoma of the nasopharynx are allowed Incurable with surgery or radiotherapy Measurable disease, defined as ≥ 1 target lesion ≥ 20 mm OR ≥ 10 mm on spiral CT scan If the only site of measurable disease is in a previously irradiated area, the patient must have documented progressive disease by tomography or biopsy-proven residual carcinoma No symptomatic brain metastases that are not stable, are not adequately controlled with fixed-dose oral steroids, are potentially life-threatening, or have required radiotherapy within the last 14 days PATIENT CHARACTERISTICS: ECOG performance status 0-2 Predicted life expectancy ≥ 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and/or ALT ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must practice effective contraceptive measures No other prior malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer No active or uncontrolled infection or other serious illnesses or medical conditions No history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent PRIOR CONCURRENT THERAPY: See Disease Characteristics No more than two prior chemotherapy regimens for locally recurrent and/or metastatic disease Prior induction chemotherapy or chemoradiotherapy with curative intent for local disease allowed provided patient has received no more than two prior chemotherapy regimens for recurrent disease Prior therapy must have been completed a minimum of 14 days prior to study AND patient has recovered No prior molecular-directed therapies, such as tyrosine kinase inhibitors and/or monoclonal antibodies At least 14 days must have elapsed between the end of radiotherapy and study registration and recovered At least 14 days since prior surgery AND wound healing has occurred At least 7 days since prior herbal extracts and tinctures with CYP3A inhibitory activity, including any of the following: Hydrastis canadensis (goldenseal) Uncaria tomentosa (cat's claw) Echinacea angustifolia roots Trifolium pratense (wild cherry) Matricaria chamomilla (chamomile) Glycyrrhiza glabra (licorice) Dillapiol Naringenin No other concurrent anticancer therapy or other investigational agents No concurrent administration of any of the following: Phenytoin Carbamazepine Rifampicin Barbiturates Hypericum perforatum (St. John's wort) CYP3A inhibitors (e.g., itraconazole)

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Hospital Universitario 12 de Octubre

Outcomes

Primary Outcome Measures

Relationship between response rate and number of CA repeats in intron 1 of the EGFR

Secondary Outcome Measures

Time to disease progression
Survival
Toxicity
Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples
Relationship between erlotinib hydrochloride exposure and outcome, toxicity, and pharmacodynamic effects

Full Information

First Posted
January 24, 2006
Last Updated
October 10, 2016
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00281866
Brief Title
Erlotinib in Treating Patients With Metastatic and/or Recurrent Head and Neck Cancer
Official Title
Genotypic-Based Pharmacodynamic Evaluation of Erlotinib (Erlotinib (Tarceva™, OSI Pharmaceuticals, Uniondale, NY) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with recurrent and/or metastatic head and neck cancer.
Detailed Description
OBJECTIVES: Primary Determine the relationship between response rate and number of CA repeats in intron 1 of the epidermal growth factor receptor (EGFR) in patients with metastatic and/or locally recurrent squamous cell carcinoma of the head and neck (SCCHN) treated with the EGFR inhibitor erlotinib hydrochloride. Secondary Determine the relationship between the number of CA repeats in intron 1 of the EGFR gene and time to disease progression and survival in patients treated with this drug. Determine cutaneous and other toxicities of erlotinib hydrochloride in patients with different numbers of CA repeats in intron 1 of the EGFR gene. Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples in patients with different numbers of CA repeats in intron 1 of the EGFR genes treated with this drug. Determine the relationship between erlotinib hydrochloride exposure (utilizing total and unbound erlotinib hydrochloride concentrations) and outcome, toxicity, and pharmacodynamic effects (upregulation of p27) in patients with different numbers of CA repeats. OUTLINE: This is a multicenter study. Patients are stratified according to genotype of intron 1 of the epidermal growth factor receptor (16/16 vs 16/20 or 20/20). Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
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, 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, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Primary Outcome Measure Information:
Title
Relationship between response rate and number of CA repeats in intron 1 of the EGFR
Secondary Outcome Measure Information:
Title
Time to disease progression
Title
Survival
Title
Toxicity
Title
Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples
Title
Relationship between erlotinib hydrochloride exposure and outcome, toxicity, and pharmacodynamic effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck Metastatic and/or locally recurrent disease No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations, as well as tumors of the parotid gland WHO Type I squamous cell carcinoma of the nasopharynx are allowed Incurable with surgery or radiotherapy Measurable disease, defined as ≥ 1 target lesion ≥ 20 mm OR ≥ 10 mm on spiral CT scan If the only site of measurable disease is in a previously irradiated area, the patient must have documented progressive disease by tomography or biopsy-proven residual carcinoma No symptomatic brain metastases that are not stable, are not adequately controlled with fixed-dose oral steroids, are potentially life-threatening, or have required radiotherapy within the last 14 days PATIENT CHARACTERISTICS: ECOG performance status 0-2 Predicted life expectancy ≥ 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and/or ALT ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must practice effective contraceptive measures No other prior malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer No active or uncontrolled infection or other serious illnesses or medical conditions No history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent PRIOR CONCURRENT THERAPY: See Disease Characteristics No more than two prior chemotherapy regimens for locally recurrent and/or metastatic disease Prior induction chemotherapy or chemoradiotherapy with curative intent for local disease allowed provided patient has received no more than two prior chemotherapy regimens for recurrent disease Prior therapy must have been completed a minimum of 14 days prior to study AND patient has recovered No prior molecular-directed therapies, such as tyrosine kinase inhibitors and/or monoclonal antibodies At least 14 days must have elapsed between the end of radiotherapy and study registration and recovered At least 14 days since prior surgery AND wound healing has occurred At least 7 days since prior herbal extracts and tinctures with CYP3A inhibitory activity, including any of the following: Hydrastis canadensis (goldenseal) Uncaria tomentosa (cat's claw) Echinacea angustifolia roots Trifolium pratense (wild cherry) Matricaria chamomilla (chamomile) Glycyrrhiza glabra (licorice) Dillapiol Naringenin No other concurrent anticancer therapy or other investigational agents No concurrent administration of any of the following: Phenytoin Carbamazepine Rifampicin Barbiturates Hypericum perforatum (St. John's wort) CYP3A inhibitors (e.g., itraconazole)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael K. Gibson, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

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

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