Phase II Study of Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity -Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer
- Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or
second primary head and neck squamous cell carcinoma (HNSCC) in patients with past
history of definitive radiation therapy for head and neck cancer. Patients in whom
the initial diagnosis was neck metastasis with suspected occult primary in the head
and neck will be eligible.
Patients with histologic variants such as spindle cell carcinoma, poorly-differentiated
keratin postive carcinoma, and lymphoepithelioma will be eligible.
- Patients may be eligible if they have unresected recurrent disease in the prior
radiation field. Patients also may be eligible if they have undergone surgical
resection of recurrent disease in the prior radiation field with any of the following
poor risk pathologic features:
- Malignant involvement of 2 or more regional lymph nodes
- Extracapsular extension of nodal disease
- Microscopically involved mucosal margins of resection (at 5 mM or less)
- Perineural involvement
- Resected soft tissue disease
- Oral cavity or oropharyngeal primaries with nodal disease at levels IV or V
- Patients must have had prior radiation for head and neck cancer with ≥ 50 % of the
recurrent tumor within areas that have been radiated to at least 45 Gy, but not
exceeding 72 Gy.
- Greater than 6 month interval from prior external beam radiation treatment. (Patients
who have received intra-operative radiation therapy [IORT] within 6 months of
registration may be eligible, if there has been no subsequent disease recurrence in
the IORT field and criteria for eligibility are otherwise met).
- KPS > or = to 70%
- Age > or = to 18years
- Adequate bone marrow function: ANC > or = to 1,500/μl, platelets > or = to
100,000/μl, Hgb > or = to 8 g/dL.
- Adequate hepatic function.
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least three months thereafter.
- Patient must sign an informed consent document.
- Anticipated lifetime spinal cord dose exceeding 54 Gy, brain stem exceeding 65 Gy,
optic chiasm exceeding 55 Gy, and optic nerves exceeding 60 Gy.
- Three or more palliative cytotoxic chemotherapy regimens in the recurrent or
metastatic disease setting.
- Pregnancy or lactation.
- Distant metastatic disease.
- Other active malignancy, other than indolent malignancies which the investigator
determines are unlikely to interfere with treatment or efficacy analysis. For
example, patients with nonmelanoma skin cancer, in situ carcinoma of the cervix, or
prostate cancer within the no current biochemical (PSA) or radiologic evidence of
disease may enroll.
- Serious concomitant medical disorders (for example, active infection, uncontrolled
seizure disorder, unstable angina) that, in the opinion of the investigator, would
compromise the safety of the patient or compromise the patient's ability to complete
- History of severe hypersensitivity reaction to docetaxel or other drugs formulated
- History of severe infusion reaction to a monoclonal antibody.
- Patients with multifocal peripheral sensory alterations or paresthesias (including
tingling) interfering with function, per patient report (example: activities of daily