Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Cytological or pathological documented squamous cell carcinoma of oral cavity, oropharynx, larynx, and hypopharynx; patients with nasopharyngeal carcinoma can be included if the patients have grades I or II tumors according to the World Health Organization (WHO) classification

• Stage III or IV according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Sixth Edition (2002)

• Unresectable or resection with significant morbidity

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Measurable Disease, defined according to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

• Bilirubin =< 1.5 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN

• Calculated creatinine clearance >= 55ml/min (using the Cockcroft-Gault formula)

• Platelet count >= 100 x 10^9 /L

• Absolute neutrophil count (ANC) >= 1.25 x 10^9 /L

• Signed informed consent

• Male and female patients with reproductive potential must use an acceptable contraceptive method

• Authorization from a dentist to begin radiation therapy

Exclusion Criteria:

• Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment

• Inability or unwillingness to comply with radiotherapy

• Evidence of clinically significant congestive heart failure; patients must be able to tolerate hydration required during cisplatin chemotherapy

• Diarrhea > grade 1 at the time of enrollment

• Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck

• Prior treatment with an investigational or marketed inhibitor of the EGFR pathway

• Use of cytochrome P450 3A4 (CYP3A4) inducers

• Presence of systemic metastases (M1)

• Pregnant or breast-feeding women

• Known human immunodeficiency virus (HIV) infection