Status:
COMPLETED
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
Lead Sponsor:
Amgen
Conditions:
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00454779
Start Date
January 1 2007
End Date
January 1 2014
Last Update
October 17 2018
Active Locations (114)
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1
Research Site
Tucson, Arizona, United States, 85715
2
Research Site
Jonesboro, Arkansas, United States, 72401
3
Research Site
Duarte, California, United States, 91010
4
Research Site
La Jolla, California, United States, 92037