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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 9
- 主要终点
- Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: erlotinib hydrochloride (Drug)
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.
干预措施: cisplatin (Drug)
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.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
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.
干预措施: intensity-modulated radiation therapy (Radiation)
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.
干预措施: quality-of-life assessment (Procedure)
Arm II (chemotherapy, radiotherapy)
Patients receive cisplatin and radiotherapy as in Arm I.
干预措施: cisplatin (Drug)
Arm II (chemotherapy, radiotherapy)
Patients receive cisplatin and radiotherapy as in Arm I.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm II (chemotherapy, radiotherapy)
Patients receive cisplatin and radiotherapy as in Arm I.
干预措施: intensity-modulated radiation therapy (Radiation)
Arm II (chemotherapy, radiotherapy)
Patients receive cisplatin and radiotherapy as in Arm I.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
时间窗: 12 weeks after the completion of therapy
Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
次要结局
- 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)
研究者
Renato Martins
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Fred Hutchinson Cancer Center