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S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Primary Purpose

Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib tosylate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Oncology Group (SWOG) Research Base

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (sorafenib tosylate)

Arm Description

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

Outcomes

Primary Outcome Measures

Response
Progression-free survival
A 95% confidence interval will be provided.
Overall survival
A 95% confidence interval will be provided.
Toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
A 95% confidence interval will be provided.
Effects of the agent on the Ras signal transduction pathway

Secondary Outcome Measures

Full Information

First Posted
November 9, 2004
Last Updated
February 27, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00096512
Brief Title
S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Official Title
Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients With Recurrent or Metastatic Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It may also stop the growth of tumor cells by stopping blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with recurrent or metastatic head and neck cance
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (sorafenib tosylate)
Arm Type
Experimental
Arm Description
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Other Intervention Name(s)
BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response
Time Frame
Up to 3 years
Title
Progression-free survival
Description
A 95% confidence interval will be provided.
Time Frame
From date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 3 years
Title
Overall survival
Description
A 95% confidence interval will be provided.
Time Frame
From date of registration to date of death due to any cause, assessed up to 3 years
Title
Toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Description
A 95% confidence interval will be provided.
Time Frame
Up to 3 years
Title
Effects of the agent on the Ras signal transduction pathway
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Williamson
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Oncology Group (SWOG) Research Base
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245
Country
United States

12. IPD Sharing Statement

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S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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