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S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
This study has been completed.

First Received on November 9, 2004.   Last Updated on July 21, 2011   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Study Start Date: October 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate (confirmed, complete and partial responses) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with sorafenib.
  • Determine the median progression-free survival and median overall survival of patients treated with this drug.

Secondary

  • Determine the qualitative and quantitative toxic effects of this drug in these patients.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following criteria:

    • Metastatic at diagnosis
    • Persistent, recurrent, or metastatic disease after definitive surgery and/or radiotherapy
    • Relapsed disease after prior induction or adjuvant therapy
  • Not amenable to salvage surgical resection
  • No newly diagnosed nonmetastatic disease
  • Measurable disease

    • If only site of measurable disease is within a prior radiotherapy port, then clearly progressive disease must be demonstrated
  • No prior or concurrent CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • SGOT or SGPT ≤ 2 times ULN

Renal

  • Creatinine < 2 times ULN

Cardiovascular

  • No significant history of cardiac disease
  • No uncontrolled hypertension
  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No cardiac ventricular arrhythmias requiring medication

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Able to take oral medication without crushing, dissolving, or chewing tablets
  • No active infection requiring systemic therapy
  • No psychological, familial, sociological, or geographical condition that would preclude study participation or compliance
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy, biologic therapy, or gene therapy for the malignancy

Chemotherapy

  • No prior chemotherapy for recurrent disease or newly diagnosed metastatic disease
  • At least 6 months since prior induction or adjuvant chemotherapy

    • No more than 1 prior induction or adjuvant regimen
  • No concurrent chemotherapy for the malignancy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy for the malignancy

Surgery

  • See Disease Characteristics
  • At least 4 weeks since prior surgery and recovered

Other

  • No concurrent therapeutic anticoagulation
  • No other concurrent therapy for the malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096512

  Show 119 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Stephen K. Williamson, MD University of Kansas
Study Chair: Chao H. Huang, MD University of Kansas
  More Information

Additional Information:
Publications:
Williamson SK, Moon J, Huang CH, et al.: A phase II trial of sorafenib in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC): a Southwest Oncology Group (SWOG) trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-6044, 310s, 2007.
Williamson SK, Moon J, Huang CH, et al.: A phase II trial of BAY 43-9006 in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC): a Southwest Oncology Group (SWOG) trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-5550, 2006.
Williamson S, Moon J, Huang C, et al.: A phase II trial of BAY 43-9006 in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). A Southwest Oncology Group (SWOG) trial. [Abstract] European Journal of Cancer Supplements 3 (2): A-995, 286, 2005.

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

Keywords provided by Southwest Oncology Group:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 09, 2012