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Head and Neck CancerPhase 2NCT01044433

Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck

A Phase 2 study testing lapatinib ditosylate and capecitabine in people with Head and Neck Cancer and Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine 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

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lapatinib ditosylate and capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Oct 2009to 3 Mar 2017
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

  • Histologically or cytologically confirmed SCCHN
  • All primary sites are eligible excluding nasopharyngeal
  • Metastatic disease or locally recurrent disease not felt amenable to curative therapy (as determined by a physician)
  • ECOG performance status 0-2
  • No prior chemotherapy in the metastatic / locally advanced, recurrent incurable setting; patients may have received prior curative-intention chemotherapy including induction chemotherapy, chemotherapy concurrent with radiation and adjuvant chemotherapy
  • No prior capecitabine; patients who have received 5-FU or other fluoropyrimidines in the curative-intention setting will not be excluded, as long as more than 6 mos have elapsed since prior 5-FU exposure
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  • No previous history of Lapatinib
  • Previous use of cetuximab in the curative-intention setting will not result in exclusion, as long as at least four weeks have elapsed since prior C225 exposure
  • Patients may have received radiation therapy in the definitive, adjuvant or metastatic setting; radiation therapy must be completed at least 14 days prior to study participation
  • ECOG performance status of 0-2 (Karnofsky >= 60%)
  • Must have normal organ and marrow function
  • Laboratory tests should be completed within 14 days prior to registration
  • Left ventricular ejection fraction (LVEF) can be determined by either echocardiography or nuclear scintigraphy and should be obtained within 21 days of enrollment
  • Platelets >= 100,000/mm^3
  • Total bilirubin =< 2
  • Albumin > 2.5
  • AST(SGOT)/ALT(SGPT) =< 5.0 X institutional upper limit of normal (for patients with hepatic metastases) =< 3.0 X institutional upper limit of normal (for patients without hepatic metastases)
  • GFR > 30 (by standard Cockroft and Gault formula)
  • LVEF >= 50%
  • Patients may receive anticoagulant medication while on study
  • Patients may not receive other antineoplastic therapies such as chemotherapy or radiation treatments while on study; patients may not receive other experimental treatments while on study; patients requiring radiation treatments during protocol-based treatment will be taken off study
  • Patients may receive concurrent bisphosphonate therapy as well as hormonal manipulations for appetite while on study
  • Patients must neither be pregnant nor expect to become pregnant while on study
  • Patients must have the ability to understand and the willingness to sign a written informed consent document
  • Adequate swallowing function or gastric-tube for drug administration
  • No disability with absorption of internal medications
  • Adequate nutritional status: Patients will not be excluded based on previous weight loss but will be required to have adequate nutrition at the time of study entry as measured by serum albumin
  • ANC >= 1,500/mm^3
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

Who cannot join

  • Patients who have received prior capecitabine chemotherapy or lapatinib
  • Patients with brain metastases may participate if they have undergone appropriate treatment for the lesion(s), are at least two weeks post treatment without evidence for post-treatment progression, have no significant neurologic symptoms, and are no longer on steroids for brain metastases
  • Patients with symptoms concerning for CNS metastases should be evaluated with imaging prior to study participation
  • Less than 3 weeks elapsed since prior exposure to chemotherapy
  • LVEF < 50% or symptomatic congestive heart failure (CHF)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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  • Pregnant women are excluded due to the potential for teratogenic or abortifacient effects of capecitabine and lapatinib; because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued prior to participation of the mother on study
  • Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion
  • Have received treatment within the last 30 days prior to study entry with any drug that has not received regulatory approval for an indication at the time of study entry
  • Previous CHF or other cardiac conditions shall not result in exclusion if the treating physician does not see contraindication to these medications; if contraindication is controversial, cardiac consultation will be obtained prior to the initiation of therapy
  • Anti-cancer therapy (other than the investigational regimen) is prohibited from 3 weeks before the first dose of investigational product through discontinuation unless otherwise noted
  • Investigational drugs are not permitted from 3 weeks (21 days) or 5 half-lives, whichever is longer, prior to the first dose and up through 30 days after the last dose of investigational product
  • CYP3A4 inducers and inhibitors, antacids, and herbal or dietary supplements
  • Concurrent radiation therapy and surgery for SCCHN is prohibited during therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase II Study of Capecitabine and Lapatinib in Squamous Cell Carcinoma of the Head and Neck

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine together with lapatinib ditosylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine and lapatinib ditosylate together works in treating patients with squamous cell cancer of the head and neck.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Overall survival (OS) will be the primary endpoint.

SECONDARY OBJECTIVES:

  1. Progression free survival (PFS). II. Time to disease progression and sites of progression. III. Response rate. IV. Toxicity of the combination in this population. V. Quality of life.

OUTLINE:

Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 5 years.

Being tested
lapatinib ditosylate, capecitabine
Medical subject headings
Head and Neck Neoplasms, Salivary Gland Neoplasms, 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

    Also called GSK572016, GW-572016, GW2016, lapatinib

    Given orally

  • capecitabineDrug

    Also called CAPE, Ro 09-1978/000, Xeloda

    Given orally

Study groups in NCT01044433
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14.
Receives: Drug: lapatinib ditosylate; Drug: capecitabine

What is being measured

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

  1. Overall Survival

    Measured: 5 years

Secondary outcomes (4)

  1. Response Rate

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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: 5 years

  2. Disease Control Rate

    Measured: 5 years

  3. Progression-free Survival

    Measured: 5 years

  4. Number of Participants With Adverse Events and Serious Adverse Events

    ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0

    Measured: 5 years

Timeline

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

  1. First posted7 Jan 2010 (estimated)
  2. Study startOct 2009
  3. Primary completion24 Sep 2015
  4. Study completion3 Mar 2017

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01044433
Sponsor's protocol ID
UPCC 15309
Other IDs
NCI-2009-01492
Status last verified
Mar 2020
First submitted
10 Dec 2009
Last updated
19 Mar 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lapatinib ditosylate and capecitabine in people with Head and Neck Cancer and Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine 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 29 inclusion and 14 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 19 Mar 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 19 Mar 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?

Overall Survival (time frame: 5 years). 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 NCT01044433.

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 19 Mar 2020.

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