Trial Information
Clinical Phase 2 Multicenter Trial Of PF-00299804 In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
Inclusion Criteria:
- Recurrent or metastatic Squamous Cell Cancer of the Head and Neck;
- Measurable disease;
- Eastern Cooperative Oncology Group (ECOG) 0-1 in Stage 1 = first 23 patients;
- Eastern Cooperative Oncology Group (ECOG) 0-2 in Stage 2 = 33 patients;
Exclusion Criteria:
- prior therapy for recurrence;
- platelets < 75,000;
- prior Epidermal Growth Factor Receptor (EGFR) therapy;
- interstitial lung disease;
- primary of nasopharynx
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Best Overall Response Rate
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A7471027
NCT ID:
NCT00768664
Start Date:
November 2008
Completion Date:
April 2012
Related Keywords:
- Head and Neck Neoplasms
- recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence
- Neoplasms
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms