Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck
2 other identifiers
interventional
204
1 country
9
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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 11, 2006
CompletedFirst Posted
Study publicly available on registry
December 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedResults Posted
Study results publicly available
April 2, 2013
CompletedMay 10, 2013
May 1, 2013
5.9 years
December 11, 2006
December 14, 2012
May 8, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
12 weeks after the completion of therapy
Secondary Outcomes (2)
Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm
30 days after the completion of therapy
Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride
Every 3 months for up to 5 years
Study Arms (2)
Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
EXPERIMENTALPatients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride PO once daily on days -7 to 47.
Arm II (chemotherapy, radiotherapy)
ACTIVE COMPARATORPatients receive cisplatin and radiotherapy as in Arm I.
Interventions
Given orally
Given IV
35 fractions
35 fractions
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Cancer Institute (NCI)collaborator
Study Sites (9)
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
University of New Mexico Health Science CCOP
Albuquerque, New Mexico, 87131, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
New Hanover Radiation Oncology Center
Wilmington, North Carolina, 28401, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee Cancer Institute-Boston Cancer Group PLC
Memphis, Tennessee, 38104, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Multicare Health System
Tacoma, Washington, 98415, United States
Related Publications (3)
Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
PMID: 25057165DERIVEDBauman JE, Austin MC, Schmidt R, Kurland BF, Vaezi A, Hayes DN, Mendez E, Parvathaneni U, Chai X, Sampath S, Martins RG. ERCC1 is a prognostic biomarker in locally advanced head and neck cancer: results from a randomised, phase II trial. Br J Cancer. 2013 Oct 15;109(8):2096-105. doi: 10.1038/bjc.2013.576. Epub 2013 Sep 24.
PMID: 24064970DERIVEDMartins RG, Parvathaneni U, Bauman JE, Sharma AK, Raez LE, Papagikos MA, Yunus F, Kurland BF, Eaton KD, Liao JJ, Mendez E, Futran N, Wang DX, Chai X, Wallace SG, Austin M, Schmidt R, Hayes DN. Cisplatin and radiotherapy with or without erlotinib in locally advanced squamous cell carcinoma of the head and neck: a randomized phase II trial. J Clin Oncol. 2013 Apr 10;31(11):1415-21. doi: 10.1200/JCO.2012.46.3299. Epub 2013 Mar 4.
PMID: 23460709DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Renato G. Martins, MD, MPH
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Renato Martins
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Record Dates
First Submitted
December 11, 2006
First Posted
December 13, 2006
Study Start
June 1, 2006
Primary Completion
May 1, 2012
Last Updated
May 10, 2013
Results First Posted
April 2, 2013
Record last verified: 2013-05