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…

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