S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients With Recurrent or Metastatic Head and Neck Cancer
4 other identifiers
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 9, 2004
CompletedFirst Posted
Study publicly available on registry
November 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedFebruary 28, 2013
February 1, 2013
1.6 years
November 9, 2004
February 27, 2013
Conditions
Outcome Measures
Primary Outcomes (5)
Response
Up to 3 years
Progression-free survival
A 95% confidence interval will be provided.
From date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 3 years
Overall survival
A 95% confidence interval will be provided.
From date of registration to date of death due to any cause, assessed up to 3 years
Toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
A 95% confidence interval will be provided.
Up to 3 years
Effects of the agent on the Ras signal transduction pathway
Up to 3 years
Study Arms (1)
Treatment (sorafenib tosylate)
EXPERIMENTALPatients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given orally
Eligibility Criteria
You may qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southwest Oncology Group (SWOG) Research Base
San Antonio, Texas, 78245, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Williamson
SWOG Cancer Research Network
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2004
First Posted
November 10, 2004
Study Start
October 1, 2004
Primary Completion
May 1, 2006
Last Updated
February 28, 2013
Record last verified: 2013-02