Clinical trial · Interventional

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

NCT00410826CI-TRIAL-00010260completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (10)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Stage III Squamous Cell Carcinoma of the Hypopharynx	Hypopharyngeal Squamous Cell Carcinoma	CURATED_BROADER	0.78
Stage III Squamous Cell Carcinoma of the Larynx	Laryngeal Squamous Cell Carcinoma	CURATED_BROADER	0.78
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity	—	UNRESOLVED	—
Stage III Squamous Cell Carcinoma of the Nasopharynx	—	UNRESOLVED	—
Stage III Squamous Cell Carcinoma of the Oropharynx	Oropharyngeal Squamous Cell Carcinoma	CURATED_BROADER	0.78
Stage IV Squamous Cell Carcinoma of the Hypopharynx	Hypopharyngeal Squamous Cell Carcinoma	CURATED_BROADER	0.78

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
3-dimensional conformal radiation therapy	Radiation	—	UNRESOLVED
cisplatin	Drug	Cisplatin	ALIAS
erlotinib hydrochloride	Drug	Erlotinib Hydrochloride	ALIAS
intensity-modulated radiation therapy	Radiation	—	UNRESOLVED
quality-of-life assessment	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
description
Patients 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.
interventionNames
1. Drug: erlotinib hydrochloride
2. Drug: cisplatin
3. Radiation: 3-dimensional conformal radiation therapy
4. Radiation: intensity-modulated radiation therapy
5. Procedure: quality-of-life assessment
type
ACTIVE_COMPARATOR
label
Arm II (chemotherapy, radiotherapy)
description
Patients receive cisplatin and radiotherapy as in Arm I.
interventionNames
1. Drug: cisplatin
2. Radiation: 3-dimensional conformal radiation therapy
3. Radiation: intensity-modulated radiation therapy

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (3)

DERIVEDPsyrri 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 25057165
DERIVEDBauman 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 24064970
DERIVEDMartins 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 23460709

Registry

Dates and enrollment

Start: Jun 1, 2006
Primary completion: May 1, 2012
Completion: —
First posted: Dec 13, 2006
Last update posted: May 10, 2013
Results first posted: Apr 2, 2013
Enrollment: 204 (actual)
Lead sponsor: University of Washington OTHER
Collaborators: National Cancer Institute (NCI)

Data updated 22 days agoSource updated May 10, 2013source: clinicaltrials

Locations

Locations by country (9)

Country	Sites	Recruiting
United States	9	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.