NCT00281866

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

January 24, 2006

Last Update Submit

October 10, 2016

Conditions

Head and Neck Cancer

Keywords

stage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent 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 oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent metastatic squamous neck cancer with occult primarymetastatic squamous neck cancer with occult primary squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

erlotinib hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Michael K. Gibson, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 25, 2006

Study Start

July 1, 2005

Primary Completion

October 1, 2006

Study Completion

March 1, 2007

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

US(1)ES(1)