Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Stage III Squamous Cell Carcinoma of the Hypopharynx Stage III Squamous Cell Carcinoma of the Larynx Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity Stage III Squamous Cell Carcinoma of the Nasopharynx Stage III Squamous Cell Carcinoma of the Oropharynx Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IV Squamous Cell Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IV Squamous Cell Carcinoma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Oropharynx |
Drug: erlotinib hydrochloride Drug: cisplatin Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy Procedure: quality-of-life assessment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm [ Time Frame: 12 weeks after the completion of therapy ] [ Designated as safety issue: No ]Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
- Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm [ Time Frame: 30 days after the completion of therapy ] [ Designated as safety issue: Yes ]
- Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride [ Time Frame: Every 3 months for up to 5 years ] [ Designated as safety issue: No ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| Enrollment: | 204 |
| Study Start Date: | June 2006 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
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.
|
Drug: erlotinib hydrochloride
Given orally
Other Names:
Drug: cisplatin
Given IV
Other Names:
Radiation: 3-dimensional conformal radiation therapy
35 fractions
Other Names:
Radiation: intensity-modulated radiation therapy
35 fractions
Other Name: IMRT
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
|
|
Active Comparator: Arm II (chemotherapy, radiotherapy)
Patients receive cisplatin and radiotherapy as in Arm I.
|
Drug: cisplatin
Given IV
Other Names:
Radiation: 3-dimensional conformal radiation therapy
35 fractions
Other Names:
Radiation: intensity-modulated radiation therapy
35 fractions
Other Name: IMRT
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
|
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 cisplatin and radiotherapy alone.
SECONDARY OBJECTIVES:
I. Evaluate whether the addition of erlotinib increases the acute and long term toxicities of cisplatin and radiotherapy, in patients with locally advanced head and neck cancer.
II. Compare the disease-free and overall survivals of patients with locally advanced head and neck cancer treated with cisplatin and radiotherapy, with and without erlotinib.
III. Evaluate whether the symptomatic improvement observed in the first week of erlotinib alone predicts for complete response and long term disease control.
IV. Correlate epidermal growth factor receptor (EGFR), p16 and excision repair cross-complementing 1 (ERCC-1) expression with response outcome to therapy with cisplatin and radiation with and without erlotinib.
V. Identify other molecular correlates that may be relevant in the pathogenesis of squamous cell carcinoma of head and neck (SCCHN) or response to therapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cisplatin intravenously (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 orally (PO) once daily (QD) on days -7 to 47.
ARM II: Patients receive cisplatin and undergo radiotherapy as in Arm I.
Within 10-14 weeks after completion of study treatment, patients with N2 or N3 disease at the time of screening undergo a neck dissection.
After completion of study treatment, patients are followed up periodically for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Alaska | |
| Alaska Oncology and Hematology LLC | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Florida | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, New Mexico | |
| University of New Mexico Health Science CCOP | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| New Hanover Radiation Oncology Center | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| University of Tennessee Cancer Institute-Boston Cancer Group PLC | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
| Multicare Health System | |
| Tacoma, Washington, United States, 98415 | |
| Principal Investigator: | Renato Martins | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
No publications provided by University of Washington
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Renato Martins, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00410826 History of Changes |
| Obsolete Identifiers: | NCT01009489 |
| Other Study ID Numbers: | 6106, NCI-2009-01546 |
| Study First Received: | December 11, 2006 |
| Results First Received: | December 14, 2012 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Laryngeal Diseases Hypopharyngeal Neoplasms Laryngeal Neoplasms Oropharyngeal Neoplasms Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Respiratory Tract Diseases Otorhinolaryngologic Diseases |
Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Neoplasms Nasopharyngeal Diseases Cisplatin Erlotinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013