At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) or variants (basaloid, adenosquamous) of oral cavity, oropharynx, hypopharynx, or larynx
- ✓Metastatic disease and/or recurrent disease following locoregional therapy, determined incurable by surgery or radiotherapy
- ✓Locoregional recurrence ≥6 months after prior radiation (if recurrence in-field) or ≥3 months after prior radiation (if recurrence solely out-of-field)
- ✓Measurable or non-measurable disease; target lesions must not be from previously irradiated field unless documented progression
- ✕Documented or symptomatic CNS metastases
- ✕History of another primary cancer (except curatively treated in situ cervical cancer, non-melanoma skin cancer, or solid tumor treated ≥2 years prior)
- ✕Nasopharyngeal carcinoma
- ✕Prior systemic chemotherapy for metastatic/recurrent SCCHN (except re-irradiation without concurrent chemotherapy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (Amended Version 20-March-2009)
In Brief
A Phase 2 clinical trial evaluating Panitumumab, Cisplatin, and 1 other intervention for Squamous Cell Carcinoma of Head and Neck. Completed, enrolled 67 participants.
Detailed Summary
Study 20080008 was a PK sub-study to study 20050251\[Japan 20050251A\]. This PK protocol was amended 20-March-2009 and is now a Phase 2 stand alone study. There are no sites participating in the U.S. This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU in subjects receiving cisplatin and 5-FU with or without panitumumab. To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the point at which the PK of panitumumab is expected to be at steady-state after a dose of 9 mg/kg given every 3 weeks.
Study Details
Timeline
Interventions
This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone