| Eligibility |
Inclusion Criteria:
1. Have histologically or cytologically confirmed metastatic or recurrent head and neck
squamous cell carcinoma from the primary lesion and/or lymph nodes of the oral cavity,
oropharynx, hypopharynx, or larynx.
2. Have measurable disease, defined as at least one lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with
conventional techniques or as >= 10 mm with spiral CT scan. See section 9.2 for the
evaluation of measurable disease.
3. Have not received any prior systemic chemotherapy for metastatic or recurrent head and
neck squamous cell carcinoma. If patients have received prior combined modality
therapy, they must be off therapy for at least 6 months.
4. Be >= 18 years of age.
5. No acute intercurrent illness or infection.
6. ECOG performance status =<2 (Karnofsky =>60%). Have normal organ and marrow function
defined as: leukocytes=>3,000/uL; absolute neutrophil count=>1,500/uL; platelets
=>100,000/uL hemoglobin >= 8g/dl; total bilirubin within normal institutional limits;
AST(SGOT)/ALT(SGPT) =<2.5 X institutional upper limit of normal if alkaline phosphate
is <ULN OR alkaline phosphatase may be up to 4x ULN if transaminases are <ULN;
creatinine =<2.0 xULN OR creatinine clearance >60 mL/min/1.73 m**2 for patients with
creatinine levels above institutional normal
7. The effects of OSI-774 on the developing human fetus at the recommended therapeutic
dose are unknown. For this reason, as other therapeutic agents used in this trial are
known to be teratogenic, women of child-bearing potential and men must agree to use
adequate contraception (hormonal or barrier method of birth control; abstinence) prior
to study entry, for the duration of study participation, and for 3 months after the
completion of therapy. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.
8. History of non-melanoma skin cancer, or other malignancies treated 5 years or more
prior to the current tumor, from which the patient has remained continually
disease-free, are eligible.
9. Ability to understand and the willingness to sign a written informed consent document.
10. Inclusion of women and minorities. Both men and women and members of all ethnic groups
are eligible for this trial. The proposed study population will consist of patients of
all ethnic backgrounds and either gender, treated at MD Anderson Cancer Center in
Houston, Texas.
Exclusion Criteria:
1. Patients who have had chemotherapy or non-palliative radiotherapy for their recurrent
or metastatic head and neck cancer.
2. Patients may not be receiving any other investigational agents.
3. Brain metastases should be excluded from this clinical trial because of their poor
prognosis and because they often develop progressive neurologic dysfunction that would
confound the evaluation of neurologic and other adverse events.
4. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to OSI-774 or other agents used in the study.
5. Patient has received prior biologic therapy targeting EGFR.
6. Signs or symptoms of acute infection requiring systemic therapy.
7. Exhibits confusion, disorientation, or has a history of major psychiatric illness that
may impair patient's understanding of the informed consent.
8. Requires total parenteral nutrition with lipids.
9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
10. Histology other than squamous cell carcinoma.
11. Refusing to sign the informed consent.
12. History of severe hypersensitivity reaction to Taxotere®.
13. Pre-existing peripheral neuropathy NCI CTC grade 2 or worse.
14. Pregnant or lactating women are excluded from this study because OSI-774 is an unknown
Class agent with the potential for teratogenic or abortifacient effects. Because there
is an unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with OSI-774, breastfeeding should be discontinued if the
mother is treated with OSI-774. These potential risks may also apply to other agents
used in this study.
15. Because patients with immune deficiency are at increased risk of lethal infections
when treated with marrow-suppressive therapy, HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with OSI-774, cisplatin, or docetaxel or other agents
administered during the study. Appropriate studies will be undertaken in patients
receiving combination anti-retroviral therapy when indicated.
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