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A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

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Trial Information

A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…


Inclusion Criteria:



- Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell
Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or
radiation therapy.

- Measurable disease by CT scan

- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

- Age: 18 years or older

- Adequate hematologic, renal, metabolic, hepatic & thyroid function

Exclusion Criteria:

- Prior systemic treatment for metastatic and/or recurrent SCCHN

- CNS metastases, or nasopharyngeal carcinoma

- History of interstitial lung disease

- History of another primary cancer

- Any co-morbid disease that would increase risk of toxicity

- Active infection requiring systemic treatment

- Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS) during the first-line treatment phase

Outcome Description:

Progression Free Survival (PFS) during the first-line treatment phase

Outcome Time Frame:

Until withdrawal of full consent or approximately 24 months after the last subject is randomized, whichever occurs first.

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20050236

NCT ID:

NCT00454779

Start Date:

January 2007

Completion Date:

December 2012

Related Keywords:

  • Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
  • SCCHNC
  • Metastatic
  • Recurrent
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Research SiteMesa, Arizona  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteLewes, Delaware  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteHays, Kansas  
Research SiteAshland, Kentucky  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteHattiesburg, Mississippi  
Research SiteBranson, Missouri  
Research SiteBillings, Montana  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteEnid, Oklahoma  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia  
Research SiteClarksburg, West Virginia  
Research SiteAppleton, Wisconsin