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Head and Neck CancerPhase 2NCT00490061

Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy

A Phase 2 study testing Lapatinib, Radiotherapy (radiation) and G.E. Healthcare 1.5T MR, systems revision 12.0 M5 in people with Head and Neck Cancer and Carcinoma, Squamous Cell, run by Quynh-Thu Le at 5 sites 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

We propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lapatinib, Radiotherapy (radiation) and G.E. Healthcare 1.5T MR, systems revision 12.0 M5
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
5 sitesUnited States
Study dates
Jul 2007to Jun 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed stage III-IV HNSCC, pathologically confirmed (HNSCC from unknown primary sites are allowed)
  • No evidence of distant metastasis
  • No prior radiation therapy to the head and neck sites.
  • Able to sign a study-specific informed consent form.
  • Women of childbearing potential and men with partners capable of producing offspring must be willing to practice acceptable methods of birth control to prevent pregnancy.
  • Left ventricular ejection fraction (LVEF) within the institutional normal range as measured by ECHO (If ECHO cannot be performed or if the Investigator feels that it is not conclusive to evaluate LVEF, then a MUGA scan should be performed).
Show all 15Show fewer
  • Having one of the following parameters that would preclude the use of concurrent CRT:
  • ECOG PS > 2.
  • Creatinine > 1.3 or calculate or measure creatinine clearance < 60 ml/min.
  • AST or ALT > 1.5 times normal limit but < 3 times normal limit
  • Total bilirubin > 1.5 mg/dL but < 3mg/dL
  • History of hearing loss that would preclude cisplatin chemotherapy. These would include the existing need of a hearing aid or a >= 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test.
  • Pre-existing peripheral neuropathy that would preclude cisplatin chemotherapy
  • Refuse or cannot tolerate chemotherapy
  • Age 18 years or older

Who cannot join

  • Known hypersensitivity to lapatinib or any of the excipients of this product (quinazolines).
  • Uncontrolled angina, arrhythmia or congestive heart failure at the time of HNSCC diagnosis and treatment.
  • History of myocardial infarction < 6 months from study entry.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  • Prior treatment with EGFR or Her2/Neu directed therapies.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Lapatinib.
  • Absolute neutrophil count < 1500/uL

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Duke University

    Durham, North Carolina, 27710

  • University of Florida Shands Cancer Center

    Gainsville, Florida, 32610

  • University of Wisconsin Cancer Center

    Madison, Wisconsin, 53792

  • Beth Israel

    New York, New York, 10003

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Multi-Institutional Phase II Study of Radiation and GW572016 (Lapatinib) for Patients With Stage III-IV Head and Neck Cancer Who Cannot Tolerate Concurrent Chemoradiotherapy.

We propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Read the detailed description

There is substantial data to suggest that EGFR and Her-2/neu expressions are important predictors for prognosis in HNSCC. EGFR blockade with a monoclonal antibody in conjunction with radiotherapy has been shown to improve survival over radiotherapy alone in patients with locally advanced HNSCC. Dual inhibition of EGFR and ErbB2 tyrosine kinases results in greater inhibitory effect of the downstream signaling pathways in cancer cells than inhibition of either receptor alone. Phase I studies in HNSCC suggested that the drug is well tolerated when delivered either alone or concurrently with cisplatin based chemoradiotherapy in HNSCC.

We propose to combine lapatinib with RT alone in patients with locally advanced HNSCC who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced HNSCC.

Being tested
Lapatinib, Radiotherapy (radiation), G.E. Healthcare 1.5T MR, systems revision 12.0 M5, DCE-MRI
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell

What participants receive

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

  • LapatinibDrug

    Also called Tykerb/Tyverb, GlaxoSmithKline

    1500 mg po daily orally

  • Radiotherapy (radiation)Procedure or surgery

    Also called IMRT - Intensity Modulated Radiotherapy

    Standard of Care

  • G.E. Healthcare 1.5T MR, systems revision 12.0 M5Device

    Also called G.E. Healthcare MRI Device and Software

    Standard of Care, used to deliver IMRT

  • DCE-MRIDevice

    Also called Dynamic contrast-enhanced magnetic resonance imaging

    A subset of patients received imaging before and after Lapatinib loading, prior to starting radiotherapy.

Study groups in NCT00490061
Study groupRoleWhat they receive
Radiotherapy and Lapatinib with DCE-MRIExperimentalDCE-MRI will precede radiotherpy before and after Lapatinib loading. 1500mg/d once daily oral Lapatinib will be administration for seven days prior to and throughout radiotherapy. Radiotherapy will be delivered as Intensity Modulated Radio Therapy (IMRT) using a G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Receives: Drug: Lapatinib; Procedure: Radiotherapy (radiation); Device: G.E. Healthcare 1.5T MR, systems revision 12.0 M5; Device: DCE-MRI

What is being measured

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

  1. Progression Free Survival

    To determine the efficacy of combining lapatinib and radiotherapy in terms of Progression-free survival (PFS) in patients with locally advanced HNSCC who cannot tolerate concurrent chemoradiotherapy.

    Progression-free survival is defined is the time from starting treatment to the time of first documented tumor progression or death due to any cause, which ever occurs first.

    Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST V1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: 2 year PFS: PFS at 2 yrs after study enrollment

Secondary outcomes (1)

  1. Overall Survival.

    Overall survival is the time from starting treatment until death due to any cause. For subjects who do not die, time to death will be censored at the time of last contact.

    Measured: Two years survival rate after study enrollment

Timeline

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

  1. First posted22 Jun 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJan 2013
  4. Study completionJun 2016

Why it stopped: Poor accrual.

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00490061
Sponsor's protocol ID
ENT0020
Other IDs
97864, LAP #109855, 8857
Status last verified
Jan 2017
First submitted
20 Jun 2007
Last updated
6 Mar 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lapatinib, Radiotherapy (radiation) and G.E. Healthcare 1.5T MR, systems revision 12.0 M5 in people with Head and Neck Cancer and Carcinoma, Squamous Cell, run by Quynh-Thu Le at 5 sites 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 15 inclusion and 7 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 6 Mar 2017). 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?

Progression Free Survival (time frame: 2 year PFS: PFS at 2 yrs after study enrollment). 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 NCT00490061.

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 6 Mar 2017.

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