A Phase II Study of OSI-774 in Combination With Cisplatin and Docetaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Study start date: January 28, 2004

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.