Patients will receive 6 weeks of treatment. On days 1, 8, 15, and 22, they will receive 15 mg/m2 or 20 mg/m2 docetaxel. On all other days (i.e., days on which the patient does not receive docetaxel), the patient will take 100, 125, or 150 mg of erlotinib.

Patients will also receive radiation therapy beginning on day 1 of treatment. Treatment will be delivered in 40 fractions. During weeks 1-3, patients will receive XRT once daily 5 times per week (Monday through Friday). The patient will not receive treatment on weekends. The target dose depends upon the target volume. During weeks 4-6, patients will receive their treatment in fractions with a minimum of 6 hours between radiation treatments.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Erlotinib, docetaxel	Phase I

Further Study Details: 

Primary Outcomes: Determine the maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation
Secondary Outcomes: Assess qualitative and quantitative acute and late toxicities associated with treatment; Assess response to treatment, time to local, regional, and distant failure, and overall survival; Prospective evaluation of swallowing function before treatment and in the follow-up period
Expected Total Enrollment:  24

Patients will receive 6 weeks of treatment. On days 1, 8, 15, and 22, they will receive 15 mg/m2 or 20 mg/m2 docetaxel. On all other days (i.e., days on which the patient does not receive docetaxel), the patient will take 100, 125, or 150 mg of erlotinib.

Patients will also receive radiation therapy beginning on day 1 of treatment. Treatment will be delivered in 40 fractions. During weeks 1-3, patients will receive XRT once daily 5 times per week (Monday through Friday). The patient will not receive treatment on weekends. The target dose depends upon the target volume. During weeks 4-6, patients will receive their treatment in fractions with a minimum of 6 hours between radiation treatments.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
• Patients should have stage III or IV disease, staged T3-4 and/or N2-3, M0
• Patients must have a Karnofsky performance status of >/= 70.
• Age >/= 18 years.
• No hematogenous metastatic disease.
• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 1500 cells/mm^3 and platelet count of > 100,000 cells/mm^3; adequate hepatic function with total bilirubin </= ULN, SGOT and SGPT may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4x ULN if SGPT and SGOT are normal. Patients who have SGPT > 1.5 ULN and alkaline phosphatase > 2.5 x ULN are not eligible.
• Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram: * CrCl male = (140 - age) x (wt. as kg)/serum Cr x 72; * CrCl female = 0.85 x (CrCl male).
• Patients must not have received previous treatment (surgery, radiation, or chemotherapy) except biopsy for the tumor under study. Patients with a history of non-melanoma skin cancer, or other previous malignancies treated 5 years or more prior to the current tumor from which the patient has remained continually disease-free, are eligible.
• Patients must sign a study-specific informed consent form.
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months thereafter.

Exclusion Criteria:

• Histology other than squamous cell carcinoma.
• Evidence of metastases (below the clavicle or distant) by clinical or radiographic means.
• Karnofsky performance status < 70
• Prior chemotherapy or therapy with inhibitors of EGFR
• Prior radiotherapy to the head and neck
• Patients with simultaneous primaries.
• Patients with a past history of malignancy (excluding non melanoma skin cancers, and cancers treated > 5 years prior for which patient remains continuously disease free).
• Pregnant or breastfeeding women are ineligible.
• Patients refusing or unable to sign the informed consent.
• Patients with pre-existing peripheral neuropathy National Cancer Institute Common Toxicity Criteria (NCI CTC) grade 2 or worse.
• Patients with a history of severe hypersensitivity reaction to Taxotere® and or polysorbate 80 must be excluded.
• Patients may not use ketoconazole, St. John’s Wort, or erythromycin.

Please refer to this study by ClinicalTrials.gov identifier  NCT00113347

Texas
      MD Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting

Study ID Numbers:  2003-1049
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 7, 2005
ClinicalTrials.gov Identifier:  NCT00113347
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05