Phase I Study Panitumumab Plus Chemoradiotherapy and Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck
- There are two parts to this study: Part A and Part B. Participants enrolled in Part A
of this study received panitumumab and chemoradiotherapy. Participants enrolled in
Part B will receive panitumumab in combination with induction chemotherapy followed by
- The main purpose of Part A was to examine the safety and the best dosing of
panitumumab, chemotherapy and radiation for the treatment of head and neck cancer. The
best dosing was determined by increasing doses of chemotherapy given in combination
with panitumumab during radiation. The chemotherapy drugs being used in Part A were
carboplatin and paclitaxel, which are standard therapies used in head and neck cancer.
These drugs were be added to radiation and this combination is called
chemoradiotherapy. The investigators have determined the best dose of panitumumab and
chemotherapy to give with radiation, Part B has now begun.
- The main purpose of Part B is to examine the safety and best dosing of chemotherapy
combined with panitumumab (called induction therapy) prior to receiving panitumumab and
chemoradiotherapy. The drugs that are used for induction chemotherapy will be
docetaxel, cisplatin and 5-fluorouracil. These drugs are also standard therapies used
in head and neck cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To identify the maximally tolerated dose of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy.
Lori J. Wirth, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|