Status:
COMPLETED
Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 I...
Detailed Description
PRIMARY OBJECTIVES: I. Compare the complete response rate in patients with locally advanced head and neck cancer, treated with cisplatin, radiotherapy and erlotinib (erlotinib hydrochloride) versus c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00410826
Start Date
June 1 2006
Last Update
May 10 2013
Active Locations (9)
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1
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
2
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
3
University of New Mexico Health Science CCOP
Albuquerque, New Mexico, United States, 87131
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27599