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Metastatic Squamous Neck Cancer With Occult PrimaryPhase 2NCT00098631

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

A Phase 2 study testing lapatinib ditosylate and laboratory biomarker analysis in people with Metastatic Squamous Neck Cancer With Occult Primary and Recurrent Metastatic Squamous Neck Cancer With Occult Primary, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. This phase II trial is studying how well lapatinib works in treating patients with recurrent and/or metastatic head and neck cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lapatinib ditosylate and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
Oct 2004to Dec 2006
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
  • Recurrent and/or metastatic disease
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No more than 2 prior treatment regimens for recurrent or metastatic disease
  • Prior chemotherapy as part of initial curative intent therapy (e.g., neoadjuvant, adjuvant, or concurrent chemotherapy) is allowed and does not count as prior therapy for recurrent or metastatic disease
Show all 42Show fewer
  • No known brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 3 months
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal
  • Creatinine clearance > 60 mL/min
  • Cardiac ejection fraction normal by echocardiogram or MUGA
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Able to swallow and retain oral or feeding tube-administered medication
  • No malabsorption syndrome
  • No requirement for IV alimentation
  • No uncontrolled inflammatory gastrointestinal disease (e.g., Crohn's disease or ulcerative colitis)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to lapatinib
  • No other uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance
  • Prior cetuximab allowed
  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No prior cumulative anthracycline therapy ≥ 450 mg/m^2 of doxorubicin or equivalent
  • More than 4 weeks since prior radiotherapy
  • No prior surgical procedure affecting absorption
  • Recovered from prior therapy
  • Other prior epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib) allowed
  • Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance in monitoring INR
  • No concurrent CYP3A4 inhibitors or inducers
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

Other trials in United States

About this study

Official title: A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN)

Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. This phase II trial is studying how well lapatinib works in treating patients with recurrent and/or metastatic head and neck cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with lapatinib.

II. Determine the progression-free survival, time to progression, and overall survival of patients treated with this drug.

III. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 cohorts according to prior epidermal growth factor receptor-targeted therapy (yes vs no).

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 40-88 patients (21-50 epidermal growth factor receptor [EGFR] inhibitor-naive patients [cohort A] and 19-38 EGFR inhibitor-pre-treated patients [cohort B]) will be accrued for this study within 4-12.6 months.

Being tested
lapatinib ditosylate, laboratory biomarker analysis
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.

  • lapatinib ditosylateDrug

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00098631
Study groupRoleWhat they receive
Treatment (lapatinib ditosylate)ExperimentalPatients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: lapatinib ditosylate; Other: laboratory biomarker analysis

What is being measured

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

  1. Objective response rate by RECIST

    The 95% confidence intervals should be provided.

    Measured: Up to 6 years

  2. Progression-free survival (PFS)

    Will be estimated using the Kaplan-Meier method.

    Measured: From start of treatment to time of disease progression, assessed up to 6 years

Secondary outcomes (3)

  1. Overall survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 6 years

  2. Changes in EGFR, pEGFR, HER2

    Paired t-tests or Wilcoxon signed rank tests will be performed to examine the magnitude and significance of pre-post treatment changes. To determine whether these markers are correlated with tumor response, both the baseline levels and the pre-post changes will be compared between responders and non-responders using the nonparametric, Wilcoxon rank-sum test. The correlative data will also be entered as covariates into a Cox regression model to determine whether they are predictive of progression-free and overall survival.

    Measured: Baseline and 12 weeks

  3. Adverse events assessed using NCI CTCAE version 3.0

    Adverse events will be summarized by type and grade.

    Measured: Up to 6 years

Timeline

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

  1. First posted8 Dec 2004 (estimated)
  2. Study startOct 2004
  3. Primary completionDec 2006

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
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098631
Sponsor's protocol ID
NCI-2012-02636
Other IDs
NCI-2012-02636, CDR0000398163, UCCRC-13394, NCI-6718, 13394A, 6718, N01CM62201, N01CM62209
Status last verified
Jan 2014
First submitted
7 Dec 2004
Last updated
7 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lapatinib ditosylate and laboratory biomarker analysis in people with Metastatic Squamous Neck Cancer With Occult Primary and Recurrent Metastatic Squamous Neck Cancer With Occult Primary, run by National Cancer Institute (NCI) 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 42 inclusion and 0 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: finished, as of the sponsor's last update on 7 Jan 2014. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective response rate by RECIST (time frame: Up to 6 years). The study lists 2 primary outcomes in all. 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 NCT00098631.

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 7 Jan 2014.

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