Clinical Trial: Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Brief Summary: This phase II trial is studying the how well saracatinib works in treating patients with metastatic or recurrent head and neck cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the median progression-free survival for patients with advanced or recurrent squamous cell carcinoma of the head and neck (HNSCC) treated with AZD0530 (saracatinib).

SECONDARY OBJEC TIVES:

I. To determine overall survival for patients with advanced or recurrent HNSCC treated with AZD0530.

II. To determine objective response rate for patients with advanced or recurrent HNSCC treated with AZD0530.

III. For patients with accessible tumors, to perform pre and post-treatment biopsies to assess the pharmacodynamic effects of AZD0530 on c-Src and downstream signaling molecules STAT3 and STAT5.

OUTLINE:

Patients receive saracatinib orally (PO) or by percutaneous endoscopic gastrostomy (PEG) tube once daily (QD) on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 12 weeks and then periodically thereafter.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Overall Response Rate [ Time Frame: From the start of treatment for up to 12 weeks ]

Response was determined as inicated in the protocol.


Original Primary Outcome: Progression-free survival

Current Secondary Outcome: Overall Survival [ Time Frame: Up to 12 weeks ]

The Kaplan-Meier method will be used to estimate overall survival.


Original Secondary Outcome:

  • Objective response rate
  • Overall Survival
  • Pharmacokinetic profile for AZD0530


Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 6, 2007
Date Started: July 2007
Date Completion:
Last Updated: April 2, 2014
Last Verified: August 2013