Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Aventis Pharmaceuticals; Genentech, Inc.
• Treatments: Docetaxel; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

1. Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.

2. Patients should have stage III or IV disease, staged T3-4 and/or N2-3, M0

3. Patients must have a Karnofsky performance status of >= 70

4. Age >/= 18 years

5. No hematogenous metastatic disease

6. 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 <= Upper Limit of Normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 * ULN if aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) are normal. Patients who have SGPT > 1.5 ULN and alkaline phosphatase > 2.5 * ULN are not eligible.

7. Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) * (weight as kg)/serum Cr * 72 CrCl female = 0.85 * (CrCl male)

8. Patients must not have received previous surgery, other than diagnostic biopsy, or radiation, for this cancer. Patients may have received neoadjuvant chemotherapy which must have been completed > 3 weeks from beginning therapy on this trial.

9. 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.

10. Patients must sign a study-specific informed consent form.

11. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months thereafter. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy.

Exclusion Criteria:

1. Histology other than squamous cell carcinoma.

2. Evidence of metastases (below the clavicle or distant) by clinical or radiographic means.

3. Karnofsky performance status < 70

4. Prior therapy with inhibitors of epidermal growth factor receptor (EGFR)

5. Prior radiotherapy to the head and neck

6. Patients with simultaneous primaries

7. 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).

8. Pregnant/breast-feeding women are ineligible.

9. Patients refusing or unable to sign the informed consent.

10. Patients with pre-existing peripheral neuropathy NCI Common Toxicity Criteria (CTC) grade 2 or worse.

11. Patients with a history of severe hypersensitivity reaction to Taxotere® and/or Polysorbate 80 must be excluded.

12. Patients may not use ketoconazole, St. John's Wort, or erythromycin.