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CompletedNCT00570232UAB0718Updated May 21, 2015Results posted

UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer

A Phase 2 interventional study of Erlotinib in Head and Neck Cancer, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by University of Alabama at Birmingham · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Sex
All
01

Study summary

The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.

Read the detailed description

An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.

02

Conditions studied

  • Head and Neck Cancer

Keywords

  • Resectable, recurrent head and neck cancer
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.

This study's enrollment of 31 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma
  2. Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed
  3. Prior radiation therapy for head and neck cancer
  4. Disease must be considered surgically resectable or candidate for curative reirradiation
  5. Adequate diagnostic workup
  6. Zubrod Performance Status 0-2
  7. Life expectancy 12 weeks
  8. Age 19, 9. Adequate laboratory data.

Exclusion criteria

Exclusion Criteria:

  1. Prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ are permissible)
  2. Patients who are pregnant or lactating
  3. Psychological condition that renders the patient unable to understand the informed consent
  4. Any situation or condition that will interfere with adherence to study activities.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Other
    Tarceva

    All patients will be prescribed erlotinib 150mg daily

    Drug: Erlotinib

Interventions

  • DrugErlotinib

    150 mg per day by mouth for 12 months

    Also known as: Tarceva

06

What researchers measure

Primary outcomes

  1. Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment

    Number of participants who had the most frequently observed undesirable effects after exposure to study drug

    Time frame: 12 - 24 months

  2. Percentage of Participants With Disease Free Status at 12 Months and 24 Months

    Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)

    Time frame: 12 - 24 months

Secondary outcomes

  1. Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.

    Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy

    Time frame: 12 - 24 months

07

Results

Posted May 21, 2015

Participant flow

Participant flow — Overall Study
MilestoneTarceva
Started31
Completed8
Not completed23
Withdrew: Adverse event10
Withdrew: Discontinued due to medical condition3
Withdrew: Discontinued due to recurrence8
Withdrew: Discontinued due to noncompliance2

Outcome measures

PrimaryNumber of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment

Number of participants who had the most frequently observed undesirable effects after exposure to study drug

Time frame:
12 - 24 months
Reported as:
Number · participants
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
participantsTarceva
rash26
diarrhea22
fatigue22
nausea6
vomiting6
headache4
PrimaryPercentage of Participants With Disease Free Status at 12 Months and 24 Months

Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)

Time frame:
12 - 24 months
Reported as:
Number · percentage of participants
Percentage of Participants With Disease Free Status at 12 Months and 24 Months
percentage of participantsTarceva
disease free rate at 12 months54
disease free rate at 24 months45
SecondaryPercentage of Participants Demonstrating Survival at 12 Months and 24 Months.

Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy

Time frame:
12 - 24 months
Reported as:
Number · percentage of participants
Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.
percentage of participantsTarceva
survival rate at 12 months61
survival rate at 24 months56

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tarceva—9/31 (29%)31/31 (100%)
Most frequent serious events
Most frequent serious events
EventTarceva
pneumonia leading to respiratory failureRespiratory, thoracic and mediastinal disorders1/31
bleeding from throatSurgical and medical procedures1/31
stridorRespiratory, thoracic and mediastinal disorders1/31
Bell's PalsyNervous system disorders1/31
pneumoniaRespiratory, thoracic and mediastinal disorders1/31
cardiac stents placedCardiac disorders1/31
H pylori infectionInfections and infestations1/31
myocardial infarctionCardiac disorders1/31
ARDSRespiratory, thoracic and mediastinal disorders1/31
Most frequent other events
Showing 10 of 24
Most frequent other events
EventTarceva
acniform rashSkin and subcutaneous tissue disorders26/31
fatigueGeneral disorders22/31
diarrheaGastrointestinal disorders22/31
hyperglycemiaMetabolism and nutrition disorders21/31
anemiaMetabolism and nutrition disorders13/31
dry skinSkin and subcutaneous tissue disorders12/31
hypoalbuminemiaMetabolism and nutrition disorders7/31
nauseaGastrointestinal disorders6/31
vomitingGastrointestinal disorders6/31
weight lossInvestigations5/31

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Tarceva
<=18 years0
Between 18 and 65 years21
>=65 years10
Sex: Female, Male
Sex: Female, Male(Participants)Tarceva
Female13
Male18
ECOG performance status
ECOG performance status(participants)Tarceva
018
18
22
unknown3
Tumor Stage at Study Start - Primary Tumor Stage (T)
Tumor Stage at Study Start - Primary Tumor Stage (T)(participants)Tarceva
T11
T23
T36
T413
not specified8
Tumor Stage at Study Start - Regional Metastasis (N)
Tumor Stage at Study Start - Regional Metastasis (N)(participants)Tarceva
N018
N12
N22
N31
not specified8
Extent of recurrence
Extent of recurrence(participants)Tarceva
Local21
Regional5
Locoregional5
Tumor subsite
Tumor subsite(participants)Tarceva
oral cavity11
larynx7
hypopharynx3
oropharynx9
unknown1
Procedure details
Procedure details(participants)Tarceva
Coincident tracheostomy13
Coincident PEG11
None7

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00570232
Lead sponsor
University of Alabama at Birmingham
Collaborators
Genentech, Inc., OSI Pharmaceuticals
Responsible party
Eben Rosenthal (Professor of Surgery, University of Alabama at Birmingham) — Principal investigator
First posted
Dec 10, 2007
Start date
Dec 2007
Primary completion
Dec 2014
Completion
Mar 2015
Results posted
May 21, 2015
Last update
May 21, 2015

Study contacts

Eben Rosenthal, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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