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Phase I Study Panitumumab Plus Chemoradiotherapy and Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck

Phase 1
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

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.

Inclusion Criteria:

- Histologically or cytologically proven squamous cell carcinoma of the head and neck
or its variants (such as basaloid squamous cell carcinoma, undifferentiated
carcinoma, or adenosquamous cell carcinoma). Primary tumor sites eligible include:
nasopharynx, oral cavity, oropharynx, hypopharynx, larynx or unknown primary SCCHN

- Stage III or IV disease, without evidence of distant metastasis, according to
American Joint Committee on Cancer

- Measurable disease, according to RECIST.

- No prior chemotherapy, radiotherapy or attempted complete resection of the SCCHN.
Diagnostic biopsy, including excisional nodal biopsy and/or tonsillectomy is allowed
if the subject has measurable disease at the time of enrollment

- 18 years of age or older

- ECOG Performance Status of 0 or 1

- No active alcohol addiction or other condition that, in the opinion of the study
investigators, would interfere with the subject's ability to comply with the
treatment plan

- Adequate hepatic and renal function

- Women of childbearing potential must have a negative pregnancy test within 2 weeks of
study entry.

Exclusion Criteria:

- Pregnant or breast feeding women

- Symptomatic peripheral neuropathy of grade 2 or higher by NCI CTCAEv3.0

- Grade 3 or more hearing loss

- History of other malignancy within the previous 5 years, except for nonmelanoma skin
cancer, carcinoma in situ of the cervix, bladder or head and neck

- Prior radiation to head and neck

- Other serious illness or medical conditions

- Patients who experienced an involuntary weight loss of more than 20% of their body
weight in the 2 months preceding study entry

- Concurrent treatment with any other anticancer therapy

- Prior therapy which affects or targets the ErbB pathway, including any inhibitors of
EGFR and ErbB2

- Participation in an investigational drug trial within 30 days of study entry

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To identify the maximally tolerated dose of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lori J. Wirth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

December 2013

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • basaloid squamous cell carcinoma
  • undifferentiated carcinoma
  • adenosquamous cell carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617