临床试验/NCT01154920

NCT01154920进行中（未招募）2 期

Randomized Phase II Trial Contrasting Weekly Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

M.D. Anderson Cancer Center4 个研究点分布在 1 个国家目标入组 128 人开始时间: 2010年7月9日最近更新: 2026年6月12日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方: M.D. Anderson Cancer Center
入组人数: 128
试验地点: 4
主要终点: Number of Patients with Progression-Free Survival (PFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical research study is to learn which chemotherapy combination is more effective in treating locally advanced head and neck squamous cell carcinoma. The side effects of these combinations will also be studied.

详细描述

Treatment on this study consists of 2 parts. The first part of your treatment is called induction chemotherapy and will last for 6-9 weeks, depending on which group you are in. The second part of treatment will be radiation therapy (either with or without chemotherapy). The type of treatment you will receive depends on the site and stage of the disease.

Study Drugs:

Paclitaxel, carboplatin, and 5-fluorouracil are designed to block cancer cells from dividing, which may cause them to die.

Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It may also damage blood vessels in tumor tissue.

Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer cells, which may cause them to die.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
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

•1. Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
•2. Biopsy material sufficient for HPV status determination available
•3. Patients should have stage IV disease, stage T0-4 N2b-2c/3 M0 (for nasopharynx patients, stage N1 is eligible). Measurable disease in either the T or N site by RECIST is required.
•4. Patients with stage Tx primary disease are eligible if there is N2b-c/3 lymphadenopathy
•5. ECOG PS 0-1
•6. Age \>/= 18 years
•7. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC \>/= 1500 cells/mm\^3 and platelet count \>/= 100,000 cells/mm\^3; adequate hepatic function with bilirubin \/=40 ml/min determined by 24 hour collection or nomogram:CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 or CrCl female = 0.85 x (CrCl male)
•9. Patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens.
•10. Patients must sign a study-specific informed consent form

排除标准

•Histology other than squamous cell carcinoma
•Proven distant metastases (below the clavicle) by clinical or radiographic measures
•Prior chemotherapy, within the previous 3 years
•Prior radiotherapy to the head and neck
•Prior cetuximab therapy or prior therapy with any other drug that targets the EGFR pathway
•Initial surgical resection rendering the patient clinically and radiologically disease free
•Simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers
•Patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free
•Men and women of childbearing potential (WOCBP) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter
•Women who are pregnant or breastfeeding
•Pre-existing peripheral neuropathy CTCAE Grade 2 or worse
•Hemoglobin < 8.0g/dL
•Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

研究组 & 干预措施

PCC Group + RT

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT)

干预措施: Paclitaxel (Drug)

PCC Group + RT

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT)

干预措施: Carboplatin (Drug)

PCC Group + RT

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT)

干预措施: Cetuximab (Drug)

PCC Group + RT + Chemotherapy

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT) + Chemotherapy

干预措施: Paclitaxel (Drug)

PCC Group + RT + Chemotherapy

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT) + Chemotherapy

干预措施: Carboplatin (Drug)

PCC Group + RT + Chemotherapy

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT) + Chemotherapy

干预措施: Cetuximab (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

干预措施: Cetuximab (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

干预措施: Docetaxel (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

干预措施: Cisplatin (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

干预措施: Fluorouracil (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

干预措施: Radiotherapy (RT) (Radiation)