NCT00281866已完成2 期
Genotypic-Based Pharmacodynamic Evaluation of Erlotinib (Erlotinib (Tarceva™, OSI Pharmaceuticals, Uniondale, NY) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 2 个国家目标入组 37 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Relationship between response rate and number of CA repeats in intron 1 of the EGFR
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with recurrent and/or metastatic head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Determine the relationship between response rate and number of CA repeats in intron 1 of the epidermal growth factor receptor (EGFR) in patients with metastatic and/or locally recurrent squamous cell carcinoma of the head and neck (SCCHN) treated with the EGFR inhibitor erlotinib hydrochloride.
Secondary
- Determine the relationship between the number of CA repeats in intron 1 of the EGFR gene and time to disease progression and survival in patients treated with this drug.
- Determine cutaneous and other toxicities of erlotinib hydrochloride in patients with different numbers of CA repeats in intron 1 of the EGFR gene.
- Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples in patients with different numbers of CA repeats in intron 1 of the EGFR genes treated with this drug.
- Determine the relationship between erlotinib hydrochloride exposure (utilizing total and unbound erlotinib hydrochloride concentrations) and outcome, toxicity, and pharmacodynamic effects (upregulation of p27) in patients with different numbers of CA repeats.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma of the head and neck
- •Metastatic and/or locally recurrent disease
- •No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations, as well as tumors of the parotid gland
- •WHO Type I squamous cell carcinoma of the nasopharynx are allowed
- •Incurable with surgery or radiotherapy
- •Measurable disease, defined as ≥ 1 target lesion ≥ 20 mm OR ≥ 10 mm on spiral CT scan
- •If the only site of measurable disease is in a previously irradiated area, the patient must have documented progressive disease by tomography or biopsy-proven residual carcinoma
- •No symptomatic brain metastases that are not stable, are not adequately controlled with fixed-dose oral steroids, are potentially life-threatening, or have required radiotherapy within the last 14 days
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Predicted life expectancy ≥ 12 weeks
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and/or ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must practice effective contraceptive measures
- •No other prior malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- •No active or uncontrolled infection or other serious illnesses or medical conditions
- •No history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No more than two prior chemotherapy regimens for locally recurrent and/or metastatic disease
- •Prior induction chemotherapy or chemoradiotherapy with curative intent for local disease allowed provided patient has received no more than two prior chemotherapy regimens for recurrent disease
- •Prior therapy must have been completed a minimum of 14 days prior to study AND patient has recovered
- •No prior molecular-directed therapies, such as tyrosine kinase inhibitors and/or monoclonal antibodies
- •At least 14 days must have elapsed between the end of radiotherapy and study registration and recovered
- •At least 14 days since prior surgery AND wound healing has occurred
- •At least 7 days since prior herbal extracts and tinctures with CYP3A inhibitory activity, including any of the following:
- •Hydrastis canadensis (goldenseal)
- •Uncaria tomentosa (cat's claw)
- •Echinacea angustifolia roots
- •Trifolium pratense (wild cherry)
- •Matricaria chamomilla (chamomile)
- •Glycyrrhiza glabra (licorice)
- •Dillapiol
- •Naringenin
- •No other concurrent anticancer therapy or other investigational agents
- •No concurrent administration of any of the following:
- •Phenytoin
- •Carbamazepine
- •Rifampicin
- •Barbiturates
- •Hypericum perforatum (St. John's wort)
- •CYP3A inhibitors (e.g., itraconazole)
排除标准
- 未提供
结局指标
主要结局
Relationship between response rate and number of CA repeats in intron 1 of the EGFR
次要结局
- Time to disease progression
- Survival
- Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples
- Toxicity
- Relationship between erlotinib hydrochloride exposure and outcome, toxicity, and pharmacodynamic effects
研究者
研究点 (2)
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