Know Cancer

or
forgot password

Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients With Recurrent or Metastatic Head and Neck Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
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 Nasopharynx, 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 Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer, Untreated Metastatic Squamous Neck Cancer With Occult Primary

Thank you

Trial Information

Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients With Recurrent or Metastatic Head and Neck Cancer


PRIMARY OBJECTIVES:

I. To evaluate the response probability (confirmed, complete and partial responses) in
patients with metastatic head and neck cancer who are treated with BAY 43-9006.

II. To evaluate median progression-free survival and median overall survival. III. To
evaluate the qualitative and quantitative toxicities of this regimen. IV. To investigate in
a preliminary manner the effects of the agent on the Ras signal transduction pathway in
tissue samples obtained prior to and after treatment.

OUTLINE: This is a multicenter study.

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

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3.3-8
months.


Inclusion Criteria:



- Patients must have histologically proven squamous cell carcinoma of the head and neck
region that is either metastatic at diagnosis or has persisted, metastasized or
recurred following definitive surgery and/or radiation therapy and is not amenable to
salvage surgical resection; selected patients who have relapsed following prior
induction or adjuvant therapy are eligible; patients with newly diagnosed
non-metastatic disease are not eligible

- Patients must be willing to submit archived tissue specimens for immunohistochemistry
correlative studies; the tissue can be from either the primary or metastatic site

- Patients must not have received prior chemotherapy for the recurrent or newly
diagnosed metastatic disease; patients who have received induction or adjuvant
chemotherapy are eligible, provided that at least six months have elapsed since the
last course of chemotherapy was administered; patients may have received only one
induction or adjuvant regimen

- Prior radiation must have been completed at least 28 days prior to registration and
all toxicities must have been resolved

- Surgery must have been completed at least 28 days prior to registration and all
complications/adverse events must have been resolved

- Patients must have measurable disease; all measurable disease must be assessed within
28 days prior to registration; if the patient also has non-measurable disease, then
non-measurable disease must be assessed within 42 days prior to registration;
patients whose only measurable disease is within a previous radiation therapy port
must demonstrate clearly progressive disease (in the opinion of the treating
investigator) prior to registration

- Patients must not be planning to receive any other concurrent therapy (i.e.
radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) for
squamous cell carcinoma of the head and neck (SCCHN) while they are on this study

- Patients must have a Zubrod performance status of 0 or 1

- Patients with active infection requiring systemic therapy are not eligible

- Patients with active or prior central nervous system (CNS) metastasis are not
eligible

- Granulocyte count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Serum creatinine < 2 x the institutional upper limit of normal

- Bilirubin =< 2 x the institutional upper limit of normal

- Alkaline phosphatase =< 2 x the institutional upper limit of normal

- SGOT or SGPT =< 2 x the institutional upper limit of normal

- Patients must not have psychological, familial, sociological, or geographical
conditions that prevent medical follow-up and compliance with the protocol treatment

- Patients must not have a significant history of cardiac disease, e.g., uncontrolled
hypertension, unstable angina, congestive-heart failure, and myocardial infarction
within the last six months, or cardiac ventricular arrhythmias requiring medication

- Patients must either be able to take oral medication without crushing, dissolving or
chewing tablets

- Patients must not have any evidence of bleeding diathesis

- Patients must not be on therapeutic anticoagulation

- No prior malignancy is allowed except for the following: adequately treated basal
cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage
I or II cancer from which the patient is currently in complete remission, or any
other cancer from which the patient has been disease-free for five years

- Pregnant or nursing women may not participate in this trial; women/men of
reproductive potential may not participate unless they have agreed to use an
effective contraceptive method

- If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next
working day

- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines

- At the time of patient registration, the treating institution's name and ID number
must be provided to the Data Operations Center in Seattle in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
has been entered into the data base

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Stephen Williamson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group (SWOG) Research Base

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03043

NCT ID:

NCT00096512

Start Date:

October 2004

Completion Date:

Related Keywords:

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

Name

Location

Southwest Oncology Group (SWOG) Research Base San Antonio, Texas  78245