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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00096512 |
Purpose
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with recurrent or metastatic head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: sorafenib tosylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients With Recurrent or Metastatic Head and Neck Cancer |
| Study Start Date: | October 2004 |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following criteria:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 6 months since prior induction or adjuvant chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 119 Study Locations| Study Chair: | Stephen K. Williamson, MD | University of Kansas |
| Study Chair: | Chao H. Huang, MD | University of Kansas |
More Information
| Responsible Party: | Laurence H. Baker, D.O., Chairman, SWOG |
| ClinicalTrials.gov Identifier: | NCT00096512 History of Changes |
| Other Study ID Numbers: | CDR0000393212, S0420, U10CA032102 |
| Study First Received: | November 9, 2004 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
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 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 |
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms Sorafenib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |