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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, 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 Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Salivary Gland Squamous Cell Carcinoma, 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 Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Untreated Metastatic Squamous Neck Cancer With Occult Primary

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Trial Information

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


PRIMARY OBJECTIVES:

I. 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.


Inclusion Criteria:



- 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

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate by RECIST

Outcome Description:

The 95% confidence intervals should be provided.

Outcome Time Frame:

Up to 6 years

Safety Issue:

No

Principal Investigator

Ezra Cohen

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02636

NCT ID:

NCT00098631

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • 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 Nasopharynx
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Salivary Gland Squamous Cell Carcinoma
  • 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 Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Untreated Metastatic Squamous Neck Cancer With Occult Primary
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Neoplasms, Unknown Primary
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470