Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer
A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer
研究概览
详细说明
This research study involves the use of a combination of two chemotherapies, cisplatin and docetaxel, which have been known to shrink head and neck cancers and are a commonly used treatment for this type of cancer. This combination will then be followed by radiation and more chemotherapy.
The purpose of this study is to see whether this combination of chemotherapy and radiation, with the addition of Cetuximab, can improve control of disease and collect information on what side effects this combination therapy may have. In addition, biologic factors (markers) will be studied that may help to predict and treat head and neck cancer patients in the future.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15232
- University of Pittsburgh Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Stage III-IVB head and neck cancer, all sites, including unknown primary tumors (bulky stage II (T2N0) lesions of the base of tongue or hypopharynx and patients with stage II nasopharyngeal cancer are also eligible) Prior to study entry the resectability and alternative treatment options will be determined by a team composed of an Ear, Nose, and Throat Surgeon, a Radiation Oncologist and a Medical Oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. Unequivocal demonstration of distant metastasis (M1) confers ineligibility
- Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas, or WHO types I-III of the nasopharynx
- Unidimensionally-measurable disease is required (RECIST)
- No prior chemotherapy, biologic/molecular targeted therapy (including any prior therapy which specifically and directly targets the EGFR pathway), or radiotherapy for head and neck cancer
- Prior surgical therapy will consist only of incisional or excisional biopsy and organ sparing procedures such as debulking of airway compromising tumors or neck dissection in a patient with an existing primary tumor (Any non-biopsy procedure must have taken place > 4 weeks but < 3 months of initiating protocol treatment)
- ECOG PS 0 or 1; 7. Organ & marrow function per protocol criteria and 8. Age of >=18 years
Exclusion Criteria:
- History of severe allergic reactions attributed to docetaxel or compounds of similar chemical or biologic composition to docetaxel, or other drugs formulated with polysorbate 80
- Uncontrolled intercurrent illness or significant history of uncontrolled cardiac disease
- Receiving any other investigational agents
- No history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, or malignancy that has been treated with a curative intent with a 5-year disease-free survival
- Significant baseline sensory or motor neurologic deficits (> grade I neuropathy); 6. HIV-positive patients and 7. Prior severe infusion reaction to a monoclonal antibody.
学习计划
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:Head and neck cancer patients
Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m^2, on day 1, docetaxel 75 mg/m^2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m^2 on day 1 and 250 mg/m^2 on subsequent weekly treatments).
After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m^2 and cetuximab 250 mg/m^2.
After completing radiation therapy, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)
|
Docetaxel 75 mg/m^2 IV over 1 hour, day 1
Cisplatin 75 mg/m^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.
Cetuximab dose will be 250 mg/m^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).
其他名称:
Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed.
Photon energies>6 MV may be utilized when appropriate to boost target localized centrally.
|
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 |
---|---|---|
Objective Response Rate (ORR)
大体时间:Up to 36 months
|
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response.
Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
|
Up to 36 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Objective Response Rate (ORR)
大体时间:Up to 36 months
|
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response.
Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
|
Up to 36 months
|
Progression-free Survival (PFS)
大体时间:Up to 36 months
|
PFS is an estimated percentage of participants without disease progression at two years (or three years) after the start of study treatment.
Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0.
The two-year and three-year PFS ended up being the same in this study.
|
Up to 36 months
|
2-year Overall Survival (OS)
大体时间:Up to 24 months
|
Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.
|
Up to 24 months
|
3-year Overall Survival (OS)
大体时间:Up to 36 months
|
Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.
|
Up to 36 months
|
Quality of Life (QOL)
大体时间:Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE
|
Effect of treatment on acute and late QOL and functional status using Functional Assessment of Cancer Therapy-General (FACT-G) with FACT-Head and Neck (FACT-HN) subscale.
The instructions to the participant were: "Below is a list of statements that other people with your illness have said are important.
By circling one number per line, please indicate how true each statement has been for you during the past 7 days."
The choices for each statement ranged from 0 (not at all) to 4 (very much).
The FACT-G and FACT-Head and Neck total scores were computed by summing 27 and 39 questions respectively, for four subscales: physical well-being, social well-being, emotional well-being, and functional well-being.
Questions for both assessments are phrased so that higher numbers/values indicate a better health state.
|
Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
EGFR-related Serum Markers
大体时间:Up to 36 months
|
Evaluation of changes in serum markers (EGFR-related) before and after therapy in the above patient population, and expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers.
|
Up to 36 months
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.