Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
2017年3月31日 更新者：Matthew Abramowitz、University of Miami
Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.
研究概览
详细说明
The investigator's approach is based on the following reasons:
- Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest.
- LDFRT will render enhanced bax activation mediated mode of cell death.
- Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.
- The toxicity profile is expected to be minimal.
Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.
研究类型
介入性
注册 (实际的)
5
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
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Miami、Florida、美国、33136
- University of Miami
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥ 6 months following the end of the prior RT.
- The recurrence must have defined bi- or uni-dimensional measurements.
- Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).
- The patient must not be a candidate for surgical resection.
- Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.
- Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl, creatinine < 1.5 mg/dl within 3 weeks prior to registration.
- Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If > 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
- Patients must sign a study-specific informed consent form prior to study entry.
Exclusion Criteria:
- Distant metastases outside of the head and neck.
- Primary disease in the nasopharynx or the salivary gland.
- Other concurrent invasive malignancies.
- Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible).
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
- Pre-existing grade ≥ 2 peripheral sensory neuropathy
- Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
- Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug with formulated with Polysorbate 80.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Erbitux, Taxotere, LD Fractionated RT
Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
|
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
其他名称：
Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
其他名称：
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Response Rate (ORR) of Participants
大体时间：Up to 6 months from End of Treatment, about 9 months
|
ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.
|
Up to 6 months from End of Treatment, about 9 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Study Participants Experiencing Treatment-Related Toxicity
大体时间：Up to 6 years
|
Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity:
|
Up to 6 years
|
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Estimated Progression-Free Survival (PFS)
大体时间：Up to 6 years
|
Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.
In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.
|
Up to 6 years
|
|
Estimated Overall Survival (OS)
大体时间：Up to 6 years
|
Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive.
OS will be measured from the start date of treatment to the date of death or last contact (censored observations).
|
Up to 6 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Matthew C Abramowitz, MD、University of Miami
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年6月3日
初级完成 (实际的)
2016年6月7日
研究完成 (实际的)
2016年6月7日
研究注册日期
首次提交
2013年2月14日
首先提交符合 QC 标准的
2013年2月19日
首次发布 (估计)
2013年2月20日
研究记录更新
最后更新发布 (实际的)
2017年5月11日
上次提交的符合 QC 标准的更新
2017年3月31日
最后验证
2017年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.