Phase II Trial of Carboplatin/Paclitaxel and Cetuximab, Followed by Carboplatin/Paclitaxel/Cetuximab and Erlotinib, With Correlative Studies in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck.
Inclusion Criteria
Criteria:
- Histologically confirmed squamous cell carcinoma of the head and neck that is
metastatic or recurrent
- No prior systemic therapy for metastatic/recurrent disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Prior chemotherapy in the induction, organ preservation or adjuvant setting is
permitted if it was completed more than 4 months prior to enrollment on the current
study
- Prior cetuximab is permitted if it was given for no more than 9 doses in combination
with radiation therapy or chemoradiation therapy for initial treatment of locally
advanced disease
- No prior erlotinib, gefitinib or lapatinib therapy is permitted; nor is prior
exposure to any investigational EGFR or panErbB reversible or irreversible inhibitor
or any prior panitumumab or investigational EGFR-directed monoclonal antibody
permitted
- Hemoglobin > 9.0 G/dl
- Absolute neutrophil count (ANC) > 1500 cells/mcl
- Creatinine (Cr) < 1.8
- Total bilirubin =< the institution's upper limit of normal (ULN), aspartate
aminotransferase (AST) and alanine transaminase (ALT) < 2 X ULN
- No chronic active viral infection
- No other malignancy within 3 years
- No chronic diarrheal condition
- Females should not be pregnant or breast feeding because chemotherapy may be harmful
to the fetus or the nursing infant; also, the effects of erlotinib and cetuximab on
the developing human fetus are unknown
- All females of childbearing potential must have a blood test or urine study within 2
weeks prior to randomization to rule out pregnancy
- Women of childbearing potential and sexually active males must use an accepted and
effective method of contraception while on treatment and for three months after the
completion of treatment
- Patients must have measurable disease based on Response Evaluation Criteria In Solid
Tumors (RECIST); baseline measurements and evaluations must be obtained within < 4
weeks of randomization; all areas of disease should be recorded and mapped out in
order to assess response and uniformity of response to therapy; disease in previously
irradiated sites is considered measurable if there has been unequivocal disease
progression or biopsy-proven residual carcinoma following radiation therapy;
persistent disease without clear-cut progression after radiotherapy can be considered
measurable if biopsy-proven at least 8 weeks after completion of radiation therapy
- Patients with a prior history of squamous cell or basal carcinoma of the skin or in
situ cervical cancer must have been curatively treated; patients with a history of
other prior malignancy must have been treated with curative intent and must have
remained disease-free for 3 years post diagnosis
- No current peripheral neuropathy > grade 2 at time of randomization
- Patients must not have any co-existing condition that would preclude full compliance
with the study
- Human immunodeficiency virus (HIV) positive patients receiving combination
anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with erlotinib
- Patients must have no history of allergic reaction to murine proteins
- Ability to understand and the willingness to sign a written informed consent
- Patients must not be receiving other investigational anti-cancer therapy
- Patients with brain metastases are not eligible
- Both men and women and members of all races and ethnic groups are eligible for this
trial