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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity

Thank you

Trial Information

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


PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

I. 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.

Inclusion Criteria


Inclusion

- 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

- 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

Exclusion

- 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

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Corey Langer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 15309

NCT ID:

NCT01044433

Start Date:

October 2009

Completion Date:

October 2013

Related Keywords:

  • Head and Neck Cancer
  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Salivary Gland Cancer
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Verrucous Carcinoma of the Larynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Salivary Gland Squamous Cell Carcinoma
  • Stage IV Salivary Gland Cancer
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IV Verrucous Carcinoma of the Larynx
  • Stage IV Verrucous Carcinoma of the Oral Cavity
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Carcinoma, Verrucous
  • Neoplasms, Unknown Primary
  • Salivary Gland Neoplasms
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Oropharyngeal Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283