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Stage III Squamous Cell Carcinoma of the HypopharynxPhase 2NCT01192815

Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck

A Phase 2 study testing erlotinib hydrochloride, intensity-modulated radiation therapy and pharmacogenomic studies in people with Stage III Squamous Cell Carcinoma of the Hypopharynx and Stage III Squamous Cell Carcinoma of the Larynx, run by Case Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib hydrochloride may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x- rays and other types of radiation to kill tumor cells. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
erlotinib hydrochloride, intensity-modulated radiation therapy and pharmacogenomic studies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jan 2011to Oct 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed locally advanced (stage III or IV) squamous cell carcinoma of the head and neck without distant metastatic disease, who are not candidates or have declined definitive surgical resection or for administration of standard chemotherapy during radiation therapy because of any of the following reasons: advanced age (>= 70 years); poor ECOG performance status (2 or 3); significant comorbidities, as reflected by a Charlson comorbidity index score of >= 3; abnormal hematopoietic, hepatic or renal function; patient's decision after applicable standard treatment options have been offered and declined by patient
  • No prior chemotherapy, radiation therapy, or investigational antitumor drug
  • Measurable disease within 4 weeks prior to registration according to the recommended RECIST response criteria
  • Life expectancy of greater than 12 weeks
  • Patients must have normal hepatic function or well compensated liver disease as defined by the Child-Pugh classification of severity of liver disease; patients with hepatic impairment (total bilirubin greater than upper limit of normal [ULN] or well-compensated disease [Child-Pugh class A] enrolled in the trial will be closely monitored, especially those with total bilirubin > 3 times ULN; dosage modifications (therapy interruption or discontinuation) may be necessary for severe changes in liver function; patient management will follow the FDA-approved labeling recommendations
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
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  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
  • Women of childbearing potential must have a negative pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and willingness to sign a written informed consent document

Who cannot join

  • All histologies other than squamous cell carcinoma
  • Salivary gland paranasal sinus and nasopharyngeal squamous cell carcinoma
  • Patients who have had prior chemotherapy or radiotherapy
  • Patients with metastatic disease
  • Patients with ECOG performance status of 4
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ERLOTINIB
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  • Patients with history of any other malignancy (except squamous cell or basal cell cancer of the skin or CIS of cervix) are ineligible unless a period of 5 years has elapsed since treatment of the previous cancer and the patient is currently disease-free from the previous cancer
  • Patients may not be receiving any other investigational agent
  • Pregnant women; breastfeeding should be discontinued

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: A Phase II Study of Erlotinib and Radiation Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck

RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib hydrochloride may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x- rays and other types of radiation to kill tumor cells. Giving erlotinib hydrochloride together with radiation therapy may be an effective treatment for patients with head and neck cancer.PURPOSE: This phase II trial is studying how well giving erlotinib hydrochloride together with radiation therapy works in treating patients with stage III-IV squamous cell cancer of the head and neck.

Read the detailed description

PRIMARY OBJECTIVES:I. To determine the time to progression of the combination of the EGFR inhibitor erlotinib and radiation therapy. SECONDARY OBJECTIVES:I. To determine objective response rate, locoregional control rate, duration of response, patterns of failure, overall survival, toxicities and quality of life outcomes of the combination of erlotinib and concurrent radiation therapy.II. To determine the pharmacokinetic profile of erlotinib. Additional analyses of the pharmacokinetic data on patients receiving daily erlotinib treatment via their feeding tube will be conducted. III. To determine the effect of treatment and dose of treatment on biologic correlates in tumor tissue and/or surrounding mucosa, EGFR expression and phosphorylation status, serum markers of angiogenic activity VEGF, sVEGFR-2, sKIT, ICAM, PDGF, fluorescence in situ hybridization (FISH) for ERBB2 for gene amplification, DNA-sequencing of EGFR and ERBB2 genes from DNA extracted from pretreatment biopsy material for mutation screening, gene expression profiling on pre-treatment biopsy material to identify predictors of response to treatment, apoptosis (TUNEL assay), Ki67 (nuclear proliferation antigen)IV. To determine the utility of the comprehensive geriatric assessment, in predicting tolerance to treatment in patients >= 65 years included in this trial. OUTLINE: Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.After completion of study treatment, patients are followed up at 6 months, every 3 months for 2 years, and then every 6 months for 2 years.

Being tested
erlotinib hydrochloride, intensity-modulated radiation therapy, pharmacogenomic studies, gene expression analysis, 3-dimensional conformal radiation therapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erlotinib hydrochlorideDrug

    Also called CP-358,774, erlotinib, OSI-774, Tarceva

    Given orally or via gastronomy tube

  • intensity-modulated radiation therapyRadiation

    Also called IMRT

    IMRT will be given in 35 fractions over 7 weeks. The primary tumor and involved nodes (PTV70) will receive 2 Gy per fractions, intermediate-risk areas (PTV63) will receive 1.8 Gy per fractions, and subclinical disease sites (PTV56) will receive 1.6 Gy perfraction. The total doses will thus be 70 Gy, 63 Gy and 56 Gy, respectively.

  • pharmacogenomic studiesOther

    Also called Pharmacogenomic Study

    Optional correlative studies

  • gene expression analysisOther

    Correlative studies

  • 3-dimensional conformal radiation therapyRadiation

    Also called 3D-CRT, conformal radiation therapy

    The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, five fractions a week to 54 Gy in 27 fractions in 5.4 weeks. The boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation for additional 16 Gy at 2.0 Gy. The primary tumor and clinically/radiologically-involved nodes will thus receive 70 Gy in 35 fractions over 7 weeks, and uninvolved upper neck nodes will receive an elective dose of 54 Gy in 5.4 weeks.

    The uninvolved lower neck nodes will receive 2.0 Gy per fraction at 3-cm depth to a total dose of 50 Gy in 25 fractions in 5.0 weeks through a matching AP or AP/PA lower neck field.

  • biopsyOther

    Also called biopsies

    Optional correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Optional correlative studies

  • laboratory biomarker analysisOther

    Optional correlative studies

  • questionnaire administrationOther

    Optional ancillary studies

  • enzyme-linked immunosorbent assayOther

    Also called ELISA

    Optional correlative studies

  • polymorphism analysisOther

    Optional correlative studies

Study groups in NCT01192815
Study groupRoleWhat they receive
Arm IExperimentalPatients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: Drug: erlotinib hydrochloride; Radiation: intensity-modulated radiation therapy; Other: pharmacogenomic studies; Other: gene expression analysis; Radiation: 3-dimensional conformal radiation therapy; Other: biopsy; Other: pharmacological study; Other: laboratory biomarker analysis; Other: questionnaire administration; Other: enzyme-linked immunosorbent assay; Other: polymorphism analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Disease Progression

    The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. Disease progression free survival (PFS) is measured from start of treatment to the date of disease progression or protocol-designated outcome, whichever occurs first and censored at the date of last followed for those survivors without disease progression

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Measured via Conventional CT and MRI

    Measured: 1 year and 10 months following study start

Secondary outcomes (5)

  1. Objective Response Rate

    Number of patients with complete response, partial response, stable disease, or progressive disease. Assessed via Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Measured via conventional CT and MRI

    Measured: 1 year and 10 months following study start

  2. Patterns of Failure

    Measured: 5 yrs following treatment

  3. Toxicities, Number of Persons With Adverse Events

    Number of participants who experienced adverse events (AE's) and serious adverse events (SAE's) during the course of the trial according to CTCAE (4.0)

    Measured: up to 2 yrs after treatment

  4. Quality of Life Assessment as Measured by Functional Assessment of Cancer Therapy (FACT-G) Test

    Quality of Life (QOL) measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL.

    Measured: after treatment at 6 mos

  5. Locoregional Control Rate

    Measured: 5 yrs following treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

Why it stopped: Funding unavailable

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01192815
Sponsor's protocol ID
CASE2309
Other IDs
NCI-2010-01885
Status last verified
May 2020
First submitted
30 Aug 2010
Last updated
12 May 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride, intensity-modulated radiation therapy and pharmacogenomic studies in people with Stage III Squamous Cell Carcinoma of the Hypopharynx and Stage III Squamous Cell Carcinoma of the Larynx, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Disease Progression (time frame: 1 year and 10 months following study start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01192815.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.

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